Takeda Oncology

# Decades of Leadership in Oncology



**CAMBRIDGE, Massachusetts and OSAKA, Japan, May 26, 2023** – Takeda [(TSE: 4502/NYSE:TAK) ](https://www.takeda.com/investors/overview/)today announced that it will present data from its expanding oncology pipeline and established product portfolio at the [59th Annual Meeting of the American Society of Clinical Oncology ](https://conferences.asco.org/)(ASCO) being held June 2-6, 2023, in Chicago, Ill. and the [31st Congress of the European Hematology Association ](https://ehaweb.org/congress/eha2023-hybrid-congress/eha2023/)(EHA), June 8-11, 2023, in Frankfurt, Germany.

The company’s presence at ASCO 2023 will underscore Takeda’s growing solid tumor portfolio, with research focused on improving treatment for metastatic colorectal cancer (CRC), as well as rare forms of oncogene-driven non-small cell lung cancer (NSCLC). Within its hematology portfolio, Takeda will present data in oral sessions at both ASCO and EHA on a head-to-head Phase 3 study comparing targeted treatments in newly diagnosed patients with Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL).

“Over the past year, we have made significant advancements with our pipeline – both in progress with our innate immunity enhancers and in further diversifying our pipeline – aiming to ultimately deliver transformative medicines to patients who need them most,” said Awny Farajallah, M.D., head, global medical affairs, oncology at Takeda. “With our aspiration to cure cancer in mind, we are excited to share data from our newly expanded solid tumor portfolio featuring results in colorectal cancer, as well as research from our established hematological portfolio where we continue to explore the potential for a new standard of care treatment in acute lymphoblastic leukemia.”

A full list of company-sponsored abstracts are available for ASCO ([here](https://assets-dam.takeda.com/image/upload/Takeda%2BOncology/siteassets/media/Takeda_Oncology_at_2023_ASCO_and_EHA/Takeda_ASCO_Abstract_5.22.23.pdf)) and EHA ([here](https://assets-dam.takeda.com/image/upload/v1684775318/Takeda%2BOncology/siteassets/media/Takeda_Oncology_at_2023_ASCO_and_EHA/Takeda_EHA_Abstract_5.22.23.pdf)).

## Takeda’s Commitment to Oncology

At Takeda Oncology, we are united by our aspiration to cure cancer and motivated every day to work harder for patients with limited or ineffective treatment options. Our agile structure and deep in-house expertise are complemented by a network of partnerships that optimize our ability to research, develop and deliver transformative medicines to people living with cancer. Building on decades of leadership in oncology and a portfolio of approved medicines for hematologic cancers and solid tumors, we are advancing a cutting-edge pipeline focused on the power of innate immunity. With inspiration from patients and innovation from everywhere, our goal is to introduce new classes of immunotherapies that can lead to deep, durable responses so that more patients can benefit from – and have access to – innovative medicines. For more information, visit  [www.takedaoncology.com.  ](https://www.takedaoncology.com/)

## About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit [www.takeda.com.](https://www.takeda.com/)

## Media Contacts:

### Japanese Media

Jun Saito

[jun.saito@takeda.com ](mailto:jun.saito@takeda.com)

### U.S. and International Media

Sara Noonan

<sara.noonan@takeda.com>

## Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

## Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

## Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

Takeda  (TSE: 4502/NYSE:TAK) today announced that it will present data from its expanding oncology pipeline and established product portfolio at the 59th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held June 2-6, 2023, in Chicago, Ill. and the 31st Congress of the European Hematology Association (EHA), June 8-11, in Frankfurt, Germany.

Takeda to Present Oncology Portfolio and Pipeline Data at the 2023 ASCO Annual Meeting and EHA Congress

* ***Prescription Drug User Fee Act (PDUFA) Target Action Date Set for November 30, 2023***

* ***NDA Includes Results From the Phase 3 FRESCO-2 and FRESCO Clinical Trials***

**OSAKA, Japan, CAMBRIDGE, Massachusetts, HONG KONG, SHANGHAI &, FLORHAM PARK, New Jersey, May 25, 2023** – Takeda [(TSE:4502/NYSE:TAK) ](https://www.takeda.com/investors/overview/)and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) ([HUTCHMED](https://www.hutch-med.com/)) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of the New Drug Application (NDA) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC). If approved, fruquintinib will be the first and only highly selective inhibitor of all three VEGF receptors approved in the U.S. for previously treated metastatic CRC.1,2 The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA is November 30, 2023.

“We are confident that fruquintinib has the potential to transform the treatment landscape for those living with previously treated metastatic colorectal cancer, as demonstrated by its strong clinical profile,” said Awny Farajallah, M.D., head of Global Medical Affairs Oncology at Takeda. “There are significant needs for patients with this disease in the U.S., and we believe fruquintinib has the potential to address these needs regardless of patients’ biomarker status. We look forward to continuing conversations with the FDA with the goal to make this therapy available to patients as soon as possible.”

The NDA for fruquintinib includes results from the Phase 3 FRESCO-2 trial along with data from the Phase 3 FRESCO trial conducted in China. FRESCO-2 is a global Phase 3 multi-regional clinical trial (MRCT) conducted in the U.S., Europe, Japan and Australia investigating fruquintinib plus best supportive care (BSC) vs placebo plus BSC in patients with previously treated metastatic CRC. The FRESCO-2 trial met its primary and key secondary endpoints, showing a significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS), respectively. Fruquintinib has been generally well tolerated in patients to date.

“The clinical benefit of fruquintinib has been confirmed in multiple ways, from global clinical studies to commercialization in China. We are pleased to have Takeda as our partner furthering development and commercialization of fruquintinib outside of China,” said Dr. Michael Shi, Head of R&D and Chief Medical Officer, HUTCHMED. “Today’s acceptance marks a significant advancement towards the goal of providing patients with previously treated metastatic colorectal cancer a much-needed therapeutic option, given the limited treatment options currently available to patients. This also supports our ongoing vision to design and develop differentiated molecules that help patients with high unmet needs globally.”

Fruquintinib is currently approved in China under the brand name ELUNATE®. Approval in China was based on the results of the FRESCO study, a Phase 3 pivotal registration trial of fruquintinib in 416 patients with metastatic CRC in China, published in *The Journal of the American Medical Association*, JAMA, in June 2018 ([NCT02314819](https://clinicaltrials.gov/ct2/show/NCT02314819)). In March 2023, HUTCHMED and Takeda [closed](https://www.hutch-med.com/closing-of-fruquintinib-license-to-takeda-outside-china/)an exclusive licensing agreement to further the global development, commercialization and manufacture of fruquintinib outside of China.

## About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of VEGFR -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity with the intention of minimizing off-target toxicities, improving tolerability and providing more consistent target coverage. Fruquintinib has been generally well tolerated in patients to date and is being investigated in combinations with other anti-cancer therapies.

## About FRESCO-2

The FRESCO-2 study is a multi-regional clinical trial conducted in the U.S., Europe, Japan and Australia investigating fruquintinib plus BSC vs placebo plus BSC in patients with previously treated metastatic CRC. As  [previously disclosed](https://www.hutch-med.com/fresco-2-met-primary-endpoint/), the 691-patient study met its primary endpoint of OS in patients with metastatic CRC who had progressed on standard chemotherapy and relevant biologic agents and who had progressed on, or were intolerant to, TAS-102 and/or regorafenib. In addition to OS, a statistically significant improvement in PFS, a key secondary endpoint, was observed. Fruquintinib has been generally well tolerated in patients to date. Summary results were initially presented at the European Society for Medical Oncology (ESMO) Congress in September 2022.4 Additional details of the study may be found at clinicaltrials.gov, using identifier  [NCT04322539](https://clinicaltrials.gov/ct2/show/NCT04322539).

## About CRC

CRC is a cancer that starts in either the colon or rectum. According to the International Agency for Research on Cancer, CRC is the third most prevalent cancer worldwide, associated with 935,000 deaths in 2020.5 In the U.S., it is estimated that 153,000 patients will be diagnosed with CRC and 53,000 deaths from the disease will occur in 2023.6 In Europe, CRC was the second most common cancer in 2020 with approximately 520,000 new cases and 245,000 deaths. In Japan, CRC was the most common cancer with an estimated 148,000 new cases and 60,000 deaths in 2020.5 Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options. Some patients with metastatic CRC may benefit from personalized therapeutic strategies based on molecular characteristics; however, most patients have tumors that do not harbor actionable mutations.7,8,9,10,11

## About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare disease, plasma-derived therapies, neuroscience, oncology and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit [www.takeda.com](https://www.takeda.com/).

## About HUTCHMED

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: [www.hutch-med.com ](https://www.hutch-med.com/)or follow us on [LinkedIn](https://www.linkedin.com/company/hutchmed/).

## Takeda Media Contacts:

### Japanese Media

Jun Saito

[Jun.Saito@takeda.com](mailto:jun.saito@takeda.com)

### U.S. and International Media

Sara Noonan

[Sara.Noonan@takeda.com](mailto:sara.noonan@takeda.com)

+1 (508) 566-2408

Emma Nash

[Emma.Nash@takeda.com](mailto:emma.nash@takeda.com)

+1 (404) 927-9113

### HUTCHMED Contacts:

#### Investor Enquiries

Mark Lee, Senior Vice President	+852 2121 8200

Annie Cheng, Vice President	+1 (973) 306-4490

#### Media Enquiries

**Americas** – Brad Miles, Solebury Strategic Communications	+1 (917) 570 7340 (Mobile) / <bmiles@soleburystrat.com>

**Europe** – Ben Atwell / Alex Shaw, FTI Consulting	+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / <HUTCHMED@fticonsulting.com>

**Asia** – Zhou Yi, Brunswick 	+852 9783 6894 (Mobile) / <HUTCHMED@brunswickgroup.com>

### Nominated Advisor

Atholl Tweedie / Freddy Crossley / Daphne Zhang
Panmure Gordon	+44 (20) 7886 2500

## Takeda Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

## Takeda Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

## HUTCHMED Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the submission of a NDA for fruquintinib for the treatment of CRC with the FDA and the timing of such submission, the therapeutic potential of fruquintinib for the treatment of patients with CRC and the further clinical development of fruquintinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the timing and outcome of clinical studies and the sufficiency of clinical data to support NDA approval of fruquintinib for the treatment of patients with CRC or other indications in the U.S. or other jurisdictions such as Europe or Japan, its potential to gain approvals from regulatory authorities on an expedited basis or at all; the efficacy and safety profile of fruquintinib; HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for fruquintinib; the timing of these events; each party’s ability to satisfy the terms and conditions under the license agreement; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials or the regulatory pathway for fruquintinib; Takeda’s ability to successfully develop and commercialize fruquintinib; and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of other drug products such as paclitaxel as combination therapeutics with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Such forward-looking statements include, without limitation, statements regarding the plan to develop and commercialize fruquintinib under the license agreement; potential payments under the license agreement, including the upfront payment and any milestone or royalty payments; potential benefits of the license agreement; and HUTCHMED’s strategy, goals and anticipated milestones, business plans and focus. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and on The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

## Takeda Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

## References

1. Xu X, et al. Efficacy and safety of regorafenib and fruquintinib as third-line treatment for colorectal cancer: a narrative review. Transl Cancer Res 2022;11(1):276-287. doi: 10.21037/tcr-20-3539

2. Sun Q, et al. (2014) Discovery of fruquintinib, a potent and highly selective small molecule inhibitor of VEGFR 1, 2, 3 tyrosine kinases for cancer therapy, Cancer Biol Ther. 2014 15:12, 1635-1645. Doi: 10.4161/15384047.2014.964087

3. Li J, Qin S, Xu RH, et al. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018;319(24):2486-2496. doi:10.1001/jama.2018.7855.

4. Dasari NA, et al. LBA25 – FRESCO-2: A global phase 3 multiregional clinical trial (MRCT) evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer. Ann Oncol. 2022 Sep;33(suppl_7): S808-S869. 10.1016/annonc/annonc1089.

5. Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249. doi:10.3322/caac.21660

6. Siegel RL, al. Colorectal cancer statistics, 2023 [published online ahead of print, 2023 Mar 1]. CA Cancer J Clin. 2023;10.3322/caac.21772. doi:10.3322/caac.21772

7. Bando H, et al. Therapeutic landscape and future direction of metastatic colorectal cancer. Nat Rev Gastroenterol Hepatol (2023). Doi:10.1038/s41575-022-00736-1

8. D'Haene N, et al. Clinical application of targeted next-generation sequencing for colorectal cancer patients: a multicentric Belgian experience. Oncotarget. 2018;9(29):20761-20768. Published 2018 Apr 17. doi:10.18632/oncotarget.25099

9. Venderbosch, et al. (2014). Mismatch repair status and braf mutation status in metastatic colorectal cancer patients: A pooled analysis of the Cairo, Cairo2, coin, and Focus Studies. Clinical Cancer Research, 20(20), 5322–5330. https://doi.org/10.1158/1078-0432.ccr-14-0332

10. Koopman, M., et al. (2009). Deficient mismatch repair system in patients with sporadic advanced colorectal cancer. British Journal of Cancer, 100(2), 266–273. https://doi.org/10.1038/sj.bjc.6604867

11. Ahcene Djaballah S, et al. HER2 in Colorectal Cancer: The Long and Winding Road From Negative Predictive Factor to Positive Actionable Target. Am Soc Clin Oncol Educ Book. 2022;42:1-14. doi:10.1200/EDBK_351354

Takeda (TSE:4502/NYSE:TAK)  and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (HUTCHMED) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of the New Drug Application (NDA) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC). 

Takeda and HUTCHMED Announce New Drug Application (NDA) for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer Granted Priority Review

***- Funds awarded to community-based organizations that are working to advance health equity for medically underserved people with cancer***

**CAMBRIDGE, Massachusetts, March 29, 2023.**– Takeda Pharmaceutical Company Limited ([TSE:4502/NYSE:TAK](https://www.takeda.com/investors/)) today announced more than $650,000 in grant funding was awarded to 18 organizations through the Improving Health Equity in Cancer: A Community Grant Program. The grants were provided to patient advocacy organizations that are helping to address the needs of medically underserved people with cancer through community-based initiatives.

“We are thrilled to be able to support advocacy organizations that are making a real impact for people with cancer in their local communities, as we know advancing health equity is not something that any one organization can do alone,” said Awny Farajallah, M.D., Head of Global Medical Affairs Oncology at Takeda. “By funding grassroots initiatives that help patients overcome the barriers to reaching their full health potential, we are able to advance equitable cancer care – something Takeda is deeply committed to.”

Eligibility for the awards required organizations to have programs that support one of three key areas - generating awareness of relevant and culturally appropriate health information, access to specialists and specialized treatments, and facilitating screening and diagnostic testing.

“By providing funding to programs that operate at a local level, we know our investment will facilitate action that has an immediate and direct impact on individual patient’s lives,” said Scott Campbell, Head of Oncology Patient Advocacy and Engagement at Takeda. “Countless local organizations are already combating health inequality in their communities, with tangible results that we are excited to contribute to.”

A full list of the awardees can be found below.

* Advocates for Community Wellness, Inc

* BLKHLTH

* Cancer Services of Allen County, Inc.

* Dia de la Mujer Latina Inc

* Grinnell Regional Medical Center

* LAHC-Leaders Advancing and Helping Communities

* Legacy Training, Inc.

* Little Red Door Cancer Agency

* Make Well Known Foundation

* National LGBT Cancer Network

* Nebraska Cancer Coalition

* Northeast Georgia Health System

* Nueva Vida Inc

* Patient Empowerment Network

* The Chrysalis Initiative

* Voice of The Experienced

* Women's Cancer Resource Center

* Worth the Wait

For more information about the Improving Health Equity in Cancer: A Community Grant Program, visit [Improving Cancer Health Equity at the Local Level](https://www.takedaoncology.com/news/our-viewpoints/improving-cancer-health-equity-at-the-local-level/).

## Takeda’s Commitment to Oncology

Our core R\&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit [www.takedaoncology.com](http://www.takedaoncology.com/).

## About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK is a global, values-based, R\&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R\&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R\&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R\&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit <https://www.takeda.com>.

For more information, visit [www.takedaoncology.com](www.takedaoncology.com).

### Media Contacts:

**U.S. and International Media** \ Sarah Gassmann \ <sgassmann@realchemistry.com> \ +1 610 836 2335

## Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

## Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: <https://www.takeda.com/investors/sec-filings/> or at [www.sec.gov](www.sec.gov). Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Takeda Pharmaceutical Company Limited today announced more than $650,000 in grant funding was awarded to 18 organizations through the Improving Health Equity in Cancer: A Community Grant Program. The grants were provided to patient advocacy organizations that are helping to address the needs of medically underserved people with cancer through community-based initiatives.

Takeda Awards More Than $650,000 to Community Organizations through Health Equity Grant Program

***- With Marketing Authorization Submissions in the U.S., European Union and Japan Planned in 2023, Fruquintinib Offers a Potential New Treatment Option for Patients with Refractory Metastatic Colorectal Cancer***

***- Licensing Agreement for Fruquintinib Strengthens Takeda’s Growing Oncology Portfolio***

**OSAKA, Japan and CAMBRIDGE, Massachusetts** – **January 23, 2023** – Takeda [TSE:4502/NYSE:TAK](https://www.takeda.com/investors/) today announced that it has entered into an exclusive licensing agreement with HUTCHMED (China) Limited (Nasdaq/AIM: HCM, HKEX: 13) and its subsidiary HUTCHMED Limited, for the further development and commercialization of fruquintinib outside of mainland China, Hong Kong and Macau.

Approved in China in 2018, fruquintinib is a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, 2 and 3. Fruquintinib is orally administered and has the potential to be used across subtypes of refractory metastatic colorectal cancer (CRC), regardless of biomarker status.

“Fruquintinib has the potential to change the treatment landscape for patients with refractory metastatic CRC who are in need of additional treatment options. We look forward to utilizing our development and commercial capabilities to expand the potential of this innovative medicine to patients beyond China,” said Teresa Bitetti, President of the Global Oncology Business Unit at Takeda. “We have a strong track record of working with companies that share our focus on bringing transformative medicines to patients around the globe who need them. Working with HUTCHMED will enable us to expand our oncology portfolio, bringing us one step closer to achieving our aspiration to cure cancer.”

Takeda is committed to oncology and developing new medicines for cancer patients who have limited or ineffective treatment options. With a strong preclinical and clinical profile, fruquintinib offers a potential new treatment option for patients with refractory metastatic CRC, supporting the shared goal of Takeda and HUTCHMED to improve the lives of those living with cancer worldwide.

“We are pleased to be partnering with a company that shares our mission to improve treatment outcomes for cancer patients and has the scale and expertise in global drug development and commercialization to advance fruquintinib globally outside of China,” said Dr. Weiguo Su, Executive Director, Chief Executive Officer and Chief Scientific Officer of HUTCHMED. “We believe that fruquintinib has a very strong future and look forward to working with Takeda to unlock its potential.”

Positive results of FRESCO-2, the Phase 3 multi-regional clinical trial of fruquintinib in refractory metastatic CRC were presented at the European Society for Medical Oncology (ESMO) Congress in September 2022. FRESCO-2 met its primary endpoint of improving overall survival (OS) in patients with metastatic CRC and was generally well tolerated.

The U.S. Food and Drug Administration (FDA) granted Fast Track designation for the development of fruquintinib for the treatment of patients with metastatic CRC in 2020. In December 2022, HUTCHMED initiated a rolling submission of a New Drug Application (NDA) for fruquintinib with the U.S. FDA, which is planned to be completed in the first half of 2023. This will be followed by planned submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and a JNDA to the Japan Pharmaceuticals and Medical Devices Agency (PMDA).

Under the terms of the agreement, Takeda will receive an exclusive worldwide license to develop and commercialize fruquintinib in all indications and territories outside of mainland China, Hong Kong and Macau. Subject to the terms of the agreement, Takeda will pay HUTCHMED $400 million upfront, up to $730 million in additional potential payments relating to regulatory, development and commercial sales milestones, as well as royalties on net sales. The deal is subject to customary closing conditions, including completion of antitrust reviews.

## About CRC

CRC is a cancer that starts in either the colon or rectum. According to the International Agency for Research on Cancer, CRC is the third most prevalent cancer worldwide, associated with 935,000 deaths in 2020. In the U.S., an estimated 155,000 patients were diagnosed with CRC and there were 54,000 deaths from the disease. In Europe, CRC was the second most common cancer in 2020 with approximately 520,000 new cases and 245,000 deaths. In Japan, CRC is the most common cancer with an estimated 148,000 new cases and 60,000 deaths in 2020. Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options.

## About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, 2 and 3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity with the intention of minimizing off-target toxicities, improving tolerability and providing more consistent target coverage. Fruquintinib has been generally well tolerated in patients to date and is being investigated in combinations with other anti-cancer therapies.

## About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited ([**TSE: 4502/NYSE: TAK**](https://www.takeda.com/investors/ ) is a global, values-based, R\&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R\&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R\&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R\&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit [**https://www.takeda.com**](https://www.takeda.com).

For more information, visit [www.takedaoncology.com](https://www.takedaoncology.com/).

### Media Contacts:

**Japanese Media**\
Jun Saito\
<jun.saito@takeda.com>\
\+81 (0) 3-3278-2325

**Media Outside Japan**\
Carrie Fernandez\
<Carrie.Fernandez@Takeda.com>\
(215) 859-2605

## Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

## Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: [https://www.takeda.com/investors/sec-filings/](https://www.takeda.com/investors/sec-filings/) or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

## Medical information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

Takeda today announced that it has entered into an exclusive licensing agreement with HUTCHMED (China) Limited (Nasdaq/AIM: HCM, HKEX: 13) and its subsidiary HUTCHMED Limited, for the further development and commercialization of fruquintinib outside of mainland China, Hong Kong and Macau.

Takeda To Acquire Exclusive Worldwide (ex-China) License of HUTCHMED’s Fruquintinib, a Highly Selective, Oral VEGFR1/2/3 Tyrosine Kinase Inhibitor

## Oncology News



# Oncology Pipeline&#xA;

Discovering and developing innovative therapies to deliver potentially transformative treatments


Science

/science/

Medicines

/medicines/

Patients

/patients/

Investors

https://www.takeda.com/investors/

Partnerships

/partnerships/

Oncology Careers

/about/careers/

## About Takeda Oncology



# Divider Section

Innovations in data, digital and technology continue to drive the latest advancements in oncology research, propelling us into the future of therapeutic development and identifying ways to more efficiently deliver new medicines to patients. As we learn to apply the tools provided by this field, we are offered the chance to discover and establish improved standards of care for people living with cancer. How can we use the latest technology to enhance our medicines and make a real difference in the lives of patients?

Listen to Takeda’s Christine Ward, Ph.D., Head of Oncology and Cell Therapy Precision & Translational Medicine, and Julie Dixon, Ph.D., Head of Global Regulatory Affairs, as they answer this question and reflect on how data, digital and technology is transforming their work and redefining possibilities for the next era of oncology.


Listen to Takeda’s Christine Ward, Ph.D., Head of Oncology and Cell Therapy Precision & Translational Medicine, and Julie Dixon, Ph.D., Head of Global Regulatory Affairs, as they answer this question and reflect on how data, digital and technology is transforming their work and redefining possibilities for the next era of oncology.

Embracing Innovation: How Today’s Tech is Transforming Translational Medicine for Patients with Cancer

Over the last decade, the multiple myeloma treatment landscape has rapidly evolved. While scientific innovation and the emergence of new therapies have helped provide a renewed sense of hope to people living with multiple myeloma, it has also made navigating the treatment journey more complex.

Given this, it is more critical than ever to ensure that we are stepping up to provide optimal education and support for patients, so they have access to the right resources and information based on their needs, concerns, desires and treatment goals. The way we can do this is by going directly to the source and hearing from patients.

At Takeda, we are focused on continuing to expand the programs that allow us to gather deep, unfiltered insights directly from patients and their care partners to better understand the needs of the myeloma community. In celebration of Myeloma Action Month, I wanted to shed light on one of Takeda Oncology’s trailblazing programs and how it has given us invaluable insights into the myeloma patient experience.

## The Patient Advocacy Liaisons

The Patient Advocacy Liaisons, or PALs, are a field-based team of myeloma experts whose mission is to deliver meaningful disease education to patients and their care partners with a focus on patient empowerment.

The program was established in 2021, and since then, the PALs have delivered more than 250 educational presentations to nearly 5,000 patients and care partners based directly on what we hear from patients – namely, the gaps in knowledge they have about their disease. These presentations take place in the support group setting or during patient organization events. These ~5,000 people have shared the information they learn within their own networks, creating a much larger reach. In the words of one of our patient leadership council members, “when you educate one patient, you educate thousands.”

PALs don’t just talk to people with myeloma, they talk *with* them, gathering information about their unmet needs. Following a presentation, PALs actively request feedback from attendees, and take those unfiltered insights and learnings into consideration when developing new educational content so it reflects the most timely and relevant educational needs facing patients today. PALs also co-create content with key opinion leaders including members of our Patient Leadership Council and expert patient advocates, ensuring it is easy to understand and optimized for the patient and care partner audience.

Our current PALs are Tara Roy MS, NP, AOCNP, and Rebekah Tobin, RN, BSN. Over the last year, they have delivered presentations aimed at helping patients understand their risk status, side effect management, lab values, cancer survivorship and wellness, infection risk, the importance of vaccinations and more. Our hope is that when patients are armed with this information, they can become stronger self-advocates and have a more-informed, ongoing dialogue with their care team, which can ultimately improve patient outcomes.

PAL Rebekah Tobin shared, “hearing the success stories post-program from people and care partners utilizing our PALs resources to help overcome their barriers is extremely rewarding. People living with myeloma and their care partners see that we take the feedback they provide and create presentations and resources which make them feel seen, heard, understood and valued. This aspect is incredibly important in distinguishing the PAL role from other advocacy roles in the industry.”

Our amazing partner organizations, like HealthTree and the International Myeloma Foundation, allow us to utilize their existing, well-established structures that provide patients and care partners with education and support to serve as forums for our programs. Patients can look out for upcoming events that the PALs will attend to deliver presentations through patient organization websites and social media channels.

Looking ahead, based on the feedback we have received, we plan to deliver presentations on strengthening communication with healthcare teams and focusing on mental health and resilience when navigating a myeloma diagnosis. We also ultimately hope to expand the PALs program into other disease areas.

“One of the most rewarding aspects as a PAL is knowing the positive impact made on patients and their caregivers as they gain the knowledge they need through our disease-based educational programs, take the information learned back to their healthcare team and feel empowered to take control of their care as they navigate through their cancer journey,” said PAL Tara Roy.


Over the last decade, the multiple myeloma treatment landscape has rapidly evolved. While scientific innovation and the emergence of new therapies have helped provide a renewed sense of hope to people living with multiple myeloma, it has also made navigating the treatment journey more complex.

Empowering Patients by Elevating Their Voices: The Patient Advocacy Liaisons Program

The decisions that a health care provider (HCP) makes immediately after a patient’s cancer diagnosis often define their treatment journey. For patients with lung cancer, one of those critical decisions is when and how to approach diagnostic testing to ensure any cancer-driving mutation(s) are properly identified. Having this information confirmed from the start allows HCPs to prescribe treatment(s) that specifically target their patient’s disease, giving them the best possible chance to optimize outcomes.1
Next-generation sequencing, or NGS, provides comprehensive testing – helping to optimize diagnosis and ensure HCPs consider all potential treatment options for their patients, including any targeted options that may be available. In rare lung cancers – like epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) non-small cell lung cancer (NSCLC) – NGS testing is a useful tool due to the distinct nature of the mutations.2
So why is this critical tool – one that has improved our understanding of cancer development and progression – not being utilized universally as standard of care?3
We gathered perspectives from several experts on what is preventing the universal adoption of NGS, and how these barriers need to be broken down to help HCPs make their care approach stronger and, ultimately, improve outcomes for patients.

## Lack of Awareness

It’s important to acknowledge that not all forms of testing are created equal. Due to the heterogeneity in length and positions of certain mutations, NGS is a more comprehensive option for detecting compared to polymerase chain reaction, or PCR, testing, which doesn’t have the same capabilities.2,4 For example, PCR testing is projected to capture about 50% of EGFR Exon20 insertion+ cases.5 Due to its limited ability to identify certain mutations, PCR tests may prevent patients from being prescribed appropriate treatments designed for their specific cancer, potentially preventing them from achieving their desired health outcomes.2,6
Wider adoption of NGS testing has enabled the identification of rare mutations that may be missed with commercially available tests, leading to a growing number of previously unidentified mutations. This has, in turn, facilitated the use of [precision medicine](https://www.fda.gov/medical-devices/in-vitro-diagnostics/precision-medicine).7-8 Despite these benefits and capabilities to pinpoint a patient’s lung cancer, NGS testing continues to be underutilized in the clinical setting.9 According to a *JCO Precision Oncology* [study](https://ascopubs.org/doi/full/10.1200/PO.22.00246) that evaluated patients with newly diagnosed advanced NSCLC, approximately 64% of potentially eligible patients for precision oncology therapies appropriate for their lung cancer did not benefit from them due to factors associated with clinical gaps, including pre-analytic biomarker testing.9 Too few clinicians are aware of the potential impact of NGS testing, and broader awareness is needed to ensure lung cancer patients are able to benefit from it.9

## Logistical Concerns

One of the common concerns from those who *are* aware of NGS tests is that results take longer than PCR tests, thus pushing back the timeline for when patients can begin treatment.3
While time is of the essence when diagnosing a disease as serious as lung cancer, waiting for the results of the NGS test will ultimately benefit the patient.3,10 HCPs should look at this issue comprehensively and recognize that prescribing the wrong therapy can cause a negative ripple effect and impact several aspects of the patient’s journey.9 Prescribing the wrong treatment may result in the patient’s cancer progressing more quickly or acquiring resistance mutations that complicate treatment sequencing.9,11-12 When NGS testing is taken into consideration at the very beginning, HCPs can ensure that all potential diagnoses and treatment options are initially explored, facilitating a path for patients to receive an optimized diagnosis and timely treatment decisions.1,9

## Reimbursement

PCR tests are the more commonly used testing method because equipment to run them is more accessible and are generally perceived as more cost-effective.3,11 However, in recent years payers have grown increasingly receptive to reimbursing for NGS tests. There are several ways coverage can be achieved for NGS testing.13 Local coverage determination, in which a Medicare Administrative Contractor reviews a test performed in that jurisdiction.

* National coverage determination, which provides access to testing for all Medicare patients nationally.
* Through private payers, which each generate their own coverage policy. Coverage policies from payers can vary significantly and may address all NGS-based tests or just one specific diagnostic test.
* Through Medicaid, in which oncology and biomarker tests are paid for directly on a state-by-state basis through diagnostic companies or health insurance.
 The most influential factor on coverage and reimbursement decisions is the clinical evidence that supports the validity of the test. As the reimbursement outlook improves and more targeted therapies are approved, pathologists anticipate an increase in NGS-based testing moving forward.13

Using NGS testing provides patients with an optimized diagnosis and thus the opportunity to receive a treatment designed to target their disease at the molecular level.1 This is why Takeda partners with industry stakeholders and companies like Thermo Fisher Scientific and Foundation Medicine, in order to address the urgent need for broader access to genomic tests, ultimately expanding treatment options for patients. Takeda remains dedicated to supporting these efforts to expand the availability and accessibility of NGS testing so that more patients can benefit from and have access to life-transforming medicine.

*Takeda Oncology and Foundation Medicine are currently partnering on the development of Foundation Medicine’s tissue- and blood-based companion diagnostics, with the goal of improving outcomes for people with* [*anaplastic lymphoma kinase-positive (ALK+)*](https://www.foundationmedicine.com/press-releases/1f035abc-35f0-417f-bf06-2115eb386579) *and EGFR Exon20 insertion+ mNSCLC. To learn more about the* [*partnership*](https://www.foundationmedicine.com/press-releases/7c611e86-4d8a-452e-9f41-8fda9901af36) *or Foundation Medicine’s approach to genomic profiling, you can visit* [*https://www.foundationmedicine.com/*](https://www.foundationmedicine.com/)*.*

### References

1. Pennell N et al. *JCO Precision Oncology*. Economic Impact of Next-Generation Sequencing Versus Single-Gene Testing to Detect Genomic Alterations in Metastatic Non-Small-Cell Lung Cancer Using a Decision Analytic Model. 2019.
2. Viteri S, Minchom A, Bazhenova L, et al. \_Molecular Oncology.\_Frequency, underdiagnosis, and heterogeneity of epidermal growth factor receptor exon 20 insertion mutations using real-world genomic datasets. 2022;1:1-8
3. Berger et al. *Nat Rev Clin Oncol.* The emerging clinical relevance of genomics in cancer medicine. 2018; 15(6):353-365
4. Khoo C, et al. *Transl Lung Cancer Res*. Molecular methods for somatic mutation testing in lung adenocarcinoma: EGFR and beyond. 2015;4:126-141
5. Ou S, Hong J, Lin H, et al. *Journal of Thoracic Oncology.* Distribution and Detectability of EGFR Exon20 Insertion Variants in Non-Small Cell Lung Cancer. 2021;16:S928-S929
6. Lin HM et al. *Journal of Thoracic Oncology* EGFR Testing Patterns and Detection of EGFR Exon 20 Insertions in the United States. 2022;3.
7. Food and Drug Administration. Precision Medicine. 2018. <https://www.fda.gov/medical-devices/in-vitro-diagnostics/precision-medicine>
8. Russo A, et al. *Oncotarget*. Heterogeneous Responses to Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitors (TKIs) in Patients with Uncommon EGFR Mutations: New Insights and Future Perspectives in this Complex Clinical Scenario. 2015;6:26814-26825.
9. Sadik H, Pritchard D, Keeling DM, et al. *JCO Precision Oncology*. Impact of Clinical Practice Gaps on the Implementation of Personalized Medicine in Advanced Non–Small-Cell Lung Cancer.
 2022;6.
10. Cainao C et al. *Biology (Basel*). Next Generation Sequencing Technology in Lung Cancer Diagnosis. 2021; 10(9)
11. Schluckebier L, Caetano R, Garay OU, et al. National Library of Medicine. *BMC Cancer*. Cost-effectiveness analysis comparing companion diagnostic tests for EGFR, ALK, and ROS1 versus next-generation sequencing (NGS) in advanced adenocarcinoma lung cancer patients. 2020.
12. Pacini L et al. *Pharmcogenomics and Personalized Medicine*. Tackling Drug Resistance in EGFR Exon 20 Insertion Mutant Lung Cancer. 2021;14:1-17.
13. Ferrara et al. Pieran Dx. 2020 NGS Testing Reimbursement Overview Strategies for Clinical NGS Deck. 2019.

The decisions that a health care provider (HCP) makes immediately after a patient's cancer diagnosis often define their treatment journey.

Breaking Down Barriers Preventing the Use of NGS

*This piece of sponsored content was produced by Re:think, the content marketing studio at The Atlantic. This article was originally published on* [*Atlantic Re:think*](https://www.theatlantic.com/sponsored/takeda-2022/can-we-cure-cancer-with-data/3779/)*.*

**Can We Cure Cancer with Data?**

Founded in the 18th  century as a traditional herbal medicine store in Osaka, Japan, Takeda has upheld a commitment to quality and innovation throughout its 240-year history. Today, as a global pharmaceutical company and a longtime innovator in the cancer research and treatment space, the organization is giving its Oncology Business Unit a dramatic data and digital transformation to better serve its patients at every step of their treatment journey. We spoke with Samer Ansari, the unit’s head of data, digital and technology, about why data and emerging technologies are critical to the discovery and development of new cancer treatments, and to the experience of patients and families suffering from these diseases.

**Atlantic Re:think:**  **Takeda’s Oncology Business Unit is unique in both structure and approach. Could you describe its mission and how emerging technology can play a role in achieving it?**

**Samer Ansari:**  Our business unit operates like a nimble biotech within a big pharmaceutical company, and it allows us to be very agile. That license to move with agility is fundamental because we are on a mission to cure cancer and must work with a sense of urgency—at the end of everything we do, there are patients waiting for innovative medicine to reach them as fast as possible. We are building industry-leading data and digital technologies that are helping us deliver on this commitment, enabling us to move at speed in our research and development and in our ability to reach people living with cancer.

**Atlantic Re:think:**  **What role do data and analytics play in cancer research and treatment?**

**Samer Ansari:**  Humans can only do so much in a small amount of time, and AI and machine learning are the augmenting factors that multiply what a human can achieve, ultimately creating greater efficiency and accuracy. The analogy I always think about is car racing. You can have the best car, but if the driver is not skilled enough to make those tight turns at the right time, the car alone cannot win the race. We have smart humans; we’ve cracked that. Now we’re empowering them with advanced data and technology capabilities to make sure that we can win the race for our patients.

Let me give you an example: A key objective for us is to make sure that our clinical trials are inclusive and diverse, and we’re trying to connect the right patient with the right trial at the right time, anywhere in the world. Data and digital technologies are a key accelerator here as we can model large and complex data sets on a frequent basis, predicting where trial-eligible patients may be and which clinical trial sites can meet trial-specific diversity goals. This then helps us connect with the right people and sites through digital channels to ensure timely engagements.

**Atlantic Re:think:**  **What kind of organizations do you work with, and what is the nature of these partnerships? Why are these strategic partnerships important in the effort to treat, and ultimately cure, cancer?**

**Samer Ansari:**  Curing cancer is not something we can do alone. We’ve curated tremendous partnerships with leading pharmaceutical companies, health-care providers, diagnostic companies, hospital centers, community centers, academia and even the tech industry. In fact, I find that Takeda Oncology is increasingly reliant on digital innovation from outside of the health-care industry to aid in accelerating our efforts to discover, develop and deliver life-transforming cancer treatments. What these diverse partnerships have in common is that we share similar values and aim to create better experiences and outcomes for people living with cancer.

**Atlantic Re:think:**  **How does the era of hybrid physical-digital experience apply to cancer and oncology?**

**Samer Ansari:**  When it comes to early diagnosis of cancer, hybrid digital innovation can play a huge role. During the coronavirus pandemic, it was really heartbreaking to see that in-person diagnostics were delayed, and health-care professionals were finding out about patients’ illness much later in their cancer stage. Smart, small, nimble technology in people’s homes could provide early indicators through real-time data analytics to detect cancer in its earliest stages. It’s a huge unmet need and an even bigger opportunity to reshape the way we think about digital technology and the application of data. The industry has a long way to go in creating that holistic experience that is outcome-driven and value-based, and enables the patient to orchestrate a more personalized experience instead of making them undergo a standard experience from our company. I am proud of the fact that Takeda is already making progress with this mindset.

**Atlantic Re:think:**  **What are some of the challenges of working with new innovative forms of technology in the pharmaceutical industry?**

**Samer Ansari:**  All of us are on a learning journey to discover the ways in which unleashing the power of data and digital can impact how we work and what we can accomplish, including Takeda Oncology. I think companies that realize digital transformation isn’t a one-and-done shift, but a fast-evolving cultural change driven by innovative mindset, will be among the first to see improved performance and competitive positioning in their efforts to best serve people throughout their health-care journey. It is also extremely important to keep ethics and trust embedded in all our innovations, and that sense of responsibility is key.

**Atlantic Re:think:**  **What are the gaps in the current applications of technology that, once filled, could improve the cancer research and treatment experience?**

**Samer Ansari:**  Currently, early diagnosis and side-effect management is critical for the person living with cancer and for their caregiver. By monitoring the patient’s ongoing health progress on a real-time basis, we have access to more information that can help us, and their health-care providers, make better outcomes. The sooner we know, the more we know and the more we can help—that’s where there’s huge potential.


Founded in the 18th  century as a traditional herbal medicine store in Osaka, Japan, Takeda has upheld a commitment to quality and innovation throughout its 240-year history. 

Atlantic Re:think Q&A with Samer Ansari, Takeda’s Oncology Business Unit Head of Data, Digital & Technology

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