Press Releases

Studies highlight the company’s ongoing commitment to advancing care for patients with myeloid malignancies

PRINCETON, New Jersey, December 9, 2024 — Taiho Oncology, Inc., presented results of two studies focused on oral therapies for patients with myelodysplastic syndromes (MDS) and MDS/myeloproliferative neoplasm (MPN), at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, Dec. 7-10, 2024, in San Diego.

• Data to be presented from an oral azacitidine plus cedazuridine (ASTX030) combination phase 1 open-label dose escalation and expansion trial
• Findings to be shared from a study analyzing real–world use patterns and clinical outcomes for patients with myelodysplastic syndrome (MDS) initiating oral decitabine and cedazuridine or intravenous/subcutaneous hypomethylating agents

Princeton, N.J., November 5, 2024 – Taiho Oncology Inc. announced today presentations at the 66th American Society of Hematology (ASH) Annual Meeting, to be held Dec. 7-10, 2024, in San Diego, CA. Among these is an oral presentation on data from a phase 1 open-label dose escalation and expansion trial of oral azacitidine plus cedazuridine (ASTX030) in patients with myelodysplastic syndromes (MDS) and MDS/myeloproliferative neoplasm (MPN) on Sunday, Dec. 8, 2024, at 4:45 p.m. PST.

PRINCETON, N.J., Jan. 23, 2024 – Taiho Oncology, Inc. announces publication of the final results from the pivotal ASCERTAIN clinical trial of fixed-dose oral decitabine and cedazuridine (INQOVI®) compared to intravenous decitabine in adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML).¹

• Retrospective analysis of patients with myelodysplastic syndromes showed trends in treatment patterns that suggest:
  • improved trend persistence with oral decitabine and cedazuridine versus intravenous/subcutaneous hypomethylating agents beyond 6 months
  • comparable persistence between oral decitabine and cedazuridine and intravenous/subcutaneous hypomethylating agents at early stages of therapy

Princeton, N.J., December 10, 2023 – Taiho Oncology, Inc. announced results of a U.S. real-world study of oral decitabine and cedazuridine (DEC-C) in patients with myelodysplastic syndromes (MDS), a rare form of blood cancer. Results of the retrospective real-world analysis of use patterns for hypomethylating agents, suggest oral DEC-C as a treatment option with the potential to reduce patient and caregiver burden, while maintaining patients on therapy. Data from the study were shared during an oral presentation (Abstract #548) at the 65^th American Society of Hematology (ASH) Annual Meeting & Exposition.

• Real-world evidence on use of oral decitabine and cedazuridine in the treatment of myelodysplastic syndromes to be featured in an oral presentation; results of several additional studies in hematological malignancies were accepted for poster presentations

Princeton, N.J., and Pleasanton, Calif., November 17, 2023 – Taiho Oncology Inc. and Astex Pharmaceuticals, Inc. announced today details of studies to be presented at the 65th American Society of Hematology (ASH) Annual Meeting, to be held Dec. 9-12, 2023, in San Diego. Among these data are the results of a real-world study of oral decitabine and cedazuridine in patients with myelodysplastic syndromes (MDS), which will be featured in an oral presentation.

Princeton, N.J., and Cambridge, Mass., August 3, 2023 – Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Oncology, Inc., announced today the launch of the REZILIENT3 trial ( NCT05973773, Researching Zipalertinib In EGFR Non-Small Cell Lung Cancer Tumors), a global Phase 3 clinical trial evaluating the combination of zipalertinib and chemotherapy as a potential first-line treatment for adult patients with previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the epidermal growth factor receptor (EGFR) exon 20 insertion mutation and who meet additional criteria.

• Approval is based on data from a pivotal clinical trial showing that treatment with LONSURF plus bevacizumab resulted in statistically significant and clinically meaningful improvements in overall survival in patients with previously treated mCRC compared to LONSURF as a single agent

PRINCETON, N.J., August 2, 2023 – Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved LONSURF® (trifluridine/tipiracil) as a single agent or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

PRINCETON, N.J., and Paris, France [May 3, 2023] – Taiho Oncology, Inc. and Servier today announced the publication of results from the pivotal Phase 3 SUNLIGHT* clinical trial of trifluridine/tipiracil (LONSURF®), alone or in combination with bevacizumab, in refractory metastatic colorectal cancer (mCRC) in the May 4, 2023, issue of the New England Journal of Medicine (NEJM).

The sNDA is supported by data from the Phase 3 SUNLIGHT clinical trial, the first to show improved efficacy over an approved comparator in adults with refractory mCRC^1,2,3,4,5,6

PRINCETON, N.J., April 18, 2023 – Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental new drug application (sNDA) for trifluridine/tipiracil (LONSURF®) as monotherapy or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. A Priority Review designation by the FDA reduces the review period of the sNDA by four months. In this case, the FDA provided an anticipated Prescription Drug User Fee Act (PDUFA) action date of August 13, 2023.

• Treatment with futibatinib resulted in durable responses and survival surpassing historical data with chemotherapy in patients with previously treated disease.
• Patients in the study reported stable quality of life over nine months of treatment.
• Data supported U.S. Food and Drug Administration accelerated approval of LYTGOBI^® (futibatinib) tablets in September 2022; continued approval may be contingent upon a confirmatory trial(s).

PRINCETON, N.J., January 18, 2023 – Taiho Oncology, Inc. today announced the publication of results from the pivotal Phase 2 FOENIX*-CCA2 clinical trial of futibatinib in the January 19, 2023 issue of The New England Journal of Medicine (NEJM). The article, “Futibatinib for Intrahepatic Cholangiocarcinoma with FGFR2 Fusions/Rearrangements,” reports on data from the FOENIX-CCA2 trial, a global open-label study evaluating patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

• Patients treated with the investigational combination of trifluridine/tipiracil in combination with bevacizumab in the pivotal Phase 3 SUNLIGHT trial achieved clinically meaningful improvement in overall survival compared to trifluridine/tipiracil alone
• Results demonstrate that trifluridine/tipiracil plus bevacizumab may be an effective and well-tolerated therapy for patients with metastatic colorectal cancer following disease progression on two prior chemotherapy regimens

PARIS, France, and PRINCETON, N.J., January 17, 2023 – Servier and Taiho Oncology, Inc., today announced the release of data from SUNLIGHT, a pivotal Phase 3 global trial evaluating the combination of trifluridine/tipiracil (LONSURF®) and bevacizumab in adults with refractory metastatic colorectal cancer (mCRC), demonstrating that the trial met its primary endpoint of overall survival (OS). These data will be shared during an oral presentation (Abstract #392020) on January 21, 2023 at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco.

PRINCETON, N.J. and PLEASANTON, CA, December 12, 2022 – Taiho Oncology, Inc. and Astex Pharmaceuticals, Inc. today announced preliminary data from the Phase 3 ASCERTAIN trial assessing overall and leukemia-free survival in adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML) harboring biallelic TP53 mutations following treatment with oral decitabine and cedazuridine (ASTX727). The data are being presented today as an oral presentation (Abstract #854) at the 64^th American Society of Hematology (ASH) Annual Meeting in New Orleans.

• LYTGOBI (pronounced “light-GOH-bee”) delivered an objective response rate of 42% and median duration of response of 9.7 months in the primary analysis of the pivotal clinical trial.
• LYTGOBI covalently binds to FGFR2 and inhibits the signaling pathway. The other approved FGFR inhibitors are reversible ATP-competitive inhibitors.
• LYTGOBI previously received breakthrough, orphan drug and priority review designations from the FDA.

PRINCETON, N.J., September 30, 2022 – Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved LYTGOBI^® tablets for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

Paris - September 12, 2022 – Servier, Taiho Oncology, Inc., and Taiho Pharmaceutical Co., Ltd., announced today that the investigational combination of trifluridine/tipiracil plus bevacizumab showed a statistically significant improvement in the primary endpoint of overall survival (OS) compared to trifluridine/tipiracil alone in a Phase III clinical trial of participants with refractory metastatic colorectal cancer (mCRC) following two chemotherapy regimens.

PRINCETON, N.J., June 3, 2022 – Taiho Oncology, Inc. announced today updated results of the Phase 2 FOENIX-CCA2 trial of futibatinib, confirming results observed in an earlier analysis. The trial was conducted in patients with locally advanced or metastatic unresectable intrahepatic (inside the liver) cholangiocarcinoma (iCCA) harboring FGFR2 gene rearrangements including fusions. These data were presented as an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

CAMBRIDGE, Mass., May 12, 2022 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Cullinan Oncology) (Nasdaq: CGEM) and Taiho Pharmaceutical Co., Ltd. (Taiho) today announced an agreement through which Taiho will acquire Cullinan Pearl Corp. (Cullinan Pearl) and co-develop and co-commercialize Cullinan Oncology’s lead program, CLN-081/TAS6417 (development code in Cullinan Oncology: CLN-081, development code in Taiho: TAS6417), an orally available, differentiated, irreversible EGFR inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild-type EGFR. Subject to customary closing conditions, including expiration or termination of the waiting period under U.S. antitrust laws, the acquisition is expected to close in the second quarter of 2022.

PRINCETON, N.J., MARCH 30, 2022 – Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for futibatinib in the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring FGFR2 gene rearrangements, including gene fusions. Futibatinib is an investigational, oral, potent, selective and irreversible small-molecule inhibitor of FGFR1, 2, 3 and 4. The FDA provided an anticipated Prescription Drug User Fee Act (PDUFA) action date of September 30, 2022.

PRINCETON, N.J., March 1, 2022 – As part of Colorectal Cancer Awareness Month throughout March, Taiho Oncology, Inc., a company focused on advancing care in colorectal and other cancers, is calling for greater awareness of both the unique challenges faced by patients living with this disease, and of the resources and support required to help patients navigate their journey.

November is Stomach Cancer Awareness Month^®*

PRINCETON, N.J., November 1, 2021 – November is a month associated with expressions of gratitude. We celebrate that which we are grateful for with family and friends, often over a holiday meal. But, while many of us will express gratitude for our health, others are struggling with theirs and may not be able to fully participate in those gatherings because they, or a loved one, have been diagnosed with stomach cancer.

• Study achieved median overall survival of 31.7 months
• Updated efficacy data demonstrated an overall response rate of 62%, with 22% of patients achieving a complete response
• INQOVI is the only oral hypomethylating agent with equivalent exposure to its intravenous (IV) form

Pleasanton, CA, September 23, 2021. Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan, today announced updated clinical data, including median overall survival (mOS), from the ASCERTAIN phase 3 trial of INQOVI®, the company’s orally administered fixed-dose combination of decitabine and cedazuridine (ASTX727 or DEC-C) in adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML). mOS was 31.7 months.

PRINCETON, N.J., September 13, 2021 – Taiho Oncology, Inc. which specializes in orally administered anti-cancer medicines and whose mission is to improve the lives of patients with cancer, their families and their caregivers, today announced data presentations from several studies for two of its investigational agents at the European Society for Medical Oncology (ESMO) Congress 2021.

Three abstracts have been selected for poster presentations, including for futibatinib (TAS-120) in advanced solid tumors, including intrahepatic cholangiocarcinoma (iCCA) and gastric cancer, and for TAS-117 in advanced solid tumors.

Dear Patients, Cancer Patient Advocacy Community and Healthcare Professionals,

As we recognize Blood Cancer Awareness Month throughout September, Taiho Oncology is pleased and honored to join patients, survivors, healthcare professionals, and advocates in enhancing awareness of blood cancer in its many forms. We come together at a time of medical advances that are bringing new hope to those with hematologic malignancies, but also at a time when blood cancer as a whole accounts for approximately 10% of all new cancer cases diagnosed in the United States.¹ Knowledge is power, which is why the awareness and education efforts associated with Blood Cancer Awareness Month and beyond are so critically important.

NCCN Oncology Research Program to oversee projects exploring oral medication combination targeting tumor suppression genes.

PLYMOUTH MEETING, PA [April 14, 2021] — The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) today announced that three projects have been selected to study oral decitabine (35 mg) and cedazuridine (100 mg). The NCCN ORP convened a Scientific Review Committee to review, evaluate, and select awardees and will provide oversight for the two-year studies—which will commence later in 2021. Research funding will be provided by a grant from Taiho Oncology, who will also supply the decitabine and cedazuridine tablet.

PRINCETON, N.J., April 11, 2021 – Taiho Oncology, Inc. today announced efficacy and safety results from the Phase 2 FOENIX-CCA2 trial, a single-arm multicenter Phase 2 study evaluating futibatinib (TAS-120) in patients with intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene rearrangements including gene fusions who have failed at least one line of therapy. The data were presented online as an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2021 Week 1 Clinical Trials Plenary from 2:00 – 3:45 PM ET on April 11, 2021.

PRINCETON, N.J., April 2, 2021 – Taiho Oncology, Inc. today announced that Phase 2 clinical data, along with preclinical and Phase 1 clinical data for futibatinib (TAS-120) will be presented during the American Association for Cancer Research (AACR) Annual Meeting 2021 Week 1, taking place virtually from April 10-15, 2021. Futibatinib is a covalently-binding FGFR inhibitor being investigated for the potential treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements including gene fusions.

PRINCETON, N.J. and TOKYO, Japan, April 1, 2021 – Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for futibatinib (TAS-120), a covalently-binding FGFR inhibitor, for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements, including gene fusions. Futibatinib is an investigational therapy and has not been approved by any regulatory authority for use in patients.

PRINCETON, N.J., March 1, 2021 – With National Colorectal Cancer Awareness Month now entering its 21st year, Taiho Oncology, Inc., announced today it has joined with leading patient advocacy organizations to help raise awareness of the unique challenges faced by patients living with colorectal cancer and provide educational resources to support their journey. Colorectal cancer (CRC) is the third most commonly diagnosed cancer in the U.S. ¹

PRINCETON, N.J., February 4, 2021 – Taiho Oncology, Inc. today announced that updated guidelines on the use of LONSURF® (trifluridine and tipiracil) have been included in the latest National Comprehensive Cancer Network® Drugs and Biologics Compendium (NCCN Compendium®) for Colon Cancer (Version 2.2021 - January 21, 2021) and Rectal Cancer (Version 1.2021 - December 22, 2020). Specifically, the “Colon Cancer”¹ and “Rectal Cancer”² sections of the NCCN Compendium, now include a Category 2A recommendation for trifluridine and tipiracil as subsequent therapy, either single agent or in combination with bevacizumab (per NCCN, an FDA-approved biosimilar is an appropriate substitute for bevacizumab), as treatment options for patients who have progressed through all available regimens.¹

PRINCETON, N.J., January 12, 2021 – Taiho Oncology, Inc. and Servier today announced that data for LONSURF® (trifluridine and tipiracil) in previously treated patients with metastatic gastric cancer (mGC) and metastatic gastroesophageal junction adenocarcinoma (mGEJC) will be presented during the 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), taking place virtually from January 15-17, 2021.

- European presence represents an important milestone in Taiho Oncology’s expanding global pharmaceutical operations

PRINCETON, N.J., December 9, 2020 – Taiho Oncology, Inc. today announced plans to expand its commercial oncology business into Europe with an opening of a European headquarters. The new headquarters will be established as a subsidiary of Taiho Pharmaceutical Co., Ltd.

PRINCETON, N.J. AND PLEASANTON, CA, December 2, 2020 – Taiho Oncology, Inc. and Astex Pharmaceuticals, Inc. today announced that data for oral decitabine and cedazuridine (INQOVI® [decitabine and cedazuridine] 35mg/100mg tablets) in intermediate and high-risk myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML) will be presented during the 62nd Annual American Society of Hematology Meeting and Exposition (ASH 2020), taking place virtually from December 5-8, 2020.

PRINCETON, N.J., November 23, 2020 – Taiho Oncology, Inc. today announced that the FDA approved hypomethylating agent INQOVI® (decitabine and cedazuridine) 35 mg/100 mg tablets, for oral use, has been included in the latest National Comprehensive Cancer Network® Clinical Practice Guidelines (NCCN Guidelines®) in Oncology for Myelodysplastic Syndromes (MDS). The NCCN Guidelines now include a category 2a recommendation that oral decitabine and cedazuridine (DEC-C) could be considered as a substitution for intravenous decitabine in the treatment of adult patients with MDS.¹

PRINCETON, N.J., November 2, 2020 –Taiho Oncology, Inc., today announced partnerships with advocacy organizations on education programs and resources to support patients living with gastric (stomach) cancer and their caregivers as part of Gastric Cancer Awareness Month (GCAM). Patients with stomach cancer require nutritious foods in order to help them recover from treatment and maintain strength; the pandemic has had a devastating impact on access to food for some people, making maintaining healthy nutrition even more of a challenge.

• NCI has announced availability to investigators of oral decitabine and cedazuridine tablets for clinical and nonclinical study proposals under the CRADA
• The collaboration is intended to study oral decitabine and cedazuridine tablets in a range of tumor types

Pleasanton, CA, - October 28, 2020. ­­-- Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd., based in Tokyo, Japan, today announces it has entered into a Cooperative Research and Development Agreement with the U.S. National Cancer Institute, part of National Institutes of Health. The agreement calls for a range of new clinical and translational studies of oral decitabine and cedazuridine tablets as an anticancer agent to be conducted in collaboration with Astex. The NCI’s Cancer Therapy Evaluation Program (CTEP) has announced they are accepting Letters of Intent for evaluation of oral decitabine and cedazuridine tablets in hematological malignancies and solid tumors, including in combination with other investigational agents. Study proposals will be reviewed by CTEP and by Astex.

PRINCETON, N.J., October 23, 2020 – Taiho Oncology, Inc., today announced the launch of its World of Hope campaign to support patients living with myelodysplastic syndrome (MDS) and bring much-needed attention to this rare and difficult-to-treat cancer during MDS World Awareness Day on October 25, 2020. MDS is a rare blood cancer that impacts approximately 4 to 5 people per 100,000 worldwide, though experts believe this number is underreported.¹ There are an estimated 60,000 to 170,000 people currently living with MDS in the U.S.²

PRINCETON, N.J., September 15, 2020 – Taiho Oncology, Inc. today announced data from three abstracts for futibatinib (TAS-120) in intrahepatic cholangiocarcinoma (iCCA) and in advanced solid tumors will be presented during the European Society for Medical Oncology (ESMO) Virtual Congress 2020 from September 19-21, 2020.

Pleasanton, CA, and Houston, TX – September 8th, 2020. ­­-- Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan, and The University of Texas MD Anderson Cancer Center today announces a strategic collaboration agreement aimed at accelerating the clinical evaluation of Astex’s pipeline of products for patients with certain types of leukemia, including myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML). The collaboration will combine MD Anderson’s clinical trials infrastructure and expertise with Astex’s clinical pipeline products.

Studies will assess safety and effectiveness of an oral combination of decitabine and cedazuridine.

PLYMOUTH MEETING, PA [September 1, 2020] — The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) today announced plans to develop a program to scientifically evaluate and facilitate clinical trials on the efficacy of decitabine and cedazuridine. This novel, fixed dose combination of the hypomethylating agent decitabine, combined with the cytidine deaminase inhibitor cedazuridine permits effective oral administration of decitabine by preventing degradation in the gut and liver. Studies will investigate decitabine and cedazuridine in hematologic malignancies. Research funding will be provided by a $2 million grant from Taiho Oncology.

Researchers from NCCN Member Institutions will evaluate futibatinib in order to improve treatment for cancers with FGFR aberrations.

PLYMOUTH MEETING, PA [July 23, 2020] — The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) today announced four projects selected to receive funding for clinical and pre-clinical evaluation of futibatinib (TAS-120). Futibatinib is an oral, irreversible, selective fibroblast growth factor receptor (FGFR) 1–4 Inhibitor. In a phase 1 dose-escalation trial, futibatinib demonstrated tolerability, pharmacodynamic activity, and preliminary antitumor activity in heavily pretreated patients with advanced solid tumors¹. NCCN will provide study oversight while Taiho Oncology is providing drug and funding.

PRINCETON, N.J., July 15, 2020 – As Taiho Oncology, Inc. (U.S.), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), continues to add early- and late-stage assets to its expanding oncology portfolio, the company today announced the hiring of Stephen Yoder, MD, MBA as Vice President, Business Development, effective June 15, 2020. In this newly created role, Dr. Yoder will be responsible for leading Taiho Oncology’s search, evaluation and due diligence activities for in-licensing and acquisition of pipeline and marketed oncology products. Dr. Yoder will report to Taiho Oncology’s Senior Vice President and Chief Medical Officer, Martin J. Birkhofer, MD.

• INQOVI is the first orally administered hypomethylating agent approved by the FDA and Health Canada
• INQOVI is a fixed-dose combination of the hypomethylating agent decitabine and the cytidine deaminase inhibitor cedazuridine, which prevents degradation of decitabine in the gastrointestinal tract and liver and enables its absorption via oral dosing
• Approval is based on the ASCERTAIN phase 3 and other supporting studies that compared systemic exposure to decitabine from oral INQOVI with exposure from IV decitabine and assessed safety and efficacy of INQOVI
• INQOVI delivers an option for intermediate and high-risk MDS and CMML patients to potentially reduce the number of office visits and to take their medication from the convenience and comfort of their homes

PRINCETON, N.J., June 4, 2020 – Taiho Oncology, Inc. today announced that preclinical data for futibatinib (TAS-120) will be presented online during the American Association for Cancer Research (AACR) Virtual Annual Meeting II 2020 from June 22-24.

PRINCETON, N.J., May 31, 2020 – Taiho Oncology, Inc. today announced efficacy and safety results of an interim analysis of FOENIX-CCA2, a single-arm multicenter Phase 2 study evaluating futibatinib (TAS-120) in patients with intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene fusions or other rearrangements, who have failed at least one line of therapy. The data were presented online at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting from 10:30 a.m.-12:00 p.m. ET on Sunday, May 31, 2020.

PRINCETON, N.J., March 2, 2020 – Taiho Oncology, Inc., announced today the support and sponsorship of vital awareness, research and patient access initiatives from leading colorectal cancer advocacy organizations, including Colorectal Cancer Alliance, Fight Colorectal Cancer and PALTOWN’s COLONTOWN®, during National Colorectal Cancer Awareness Month in March. Now in the 20th year, National Colorectal Cancer Awareness Month aims to improve the lives of colorectal cancer patients, survivors and their caregivers across the United States (U.S.).

Astex Pharmaceuticals announces U.S. Food and Drug Administration (FDA) acceptance for review of an NDA for the combination oral hypomethylating agent cedazuridine and decitabine (ASTX727 or oral C-DEC), for the treatment of MDS and CMML

• NDA is supported by data from the phase 3 ASCERTAIN study of oral C-DEC in adults with intermediate- and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML)
• FDA designated the application for Priority Review
• Potential for oral C-DEC to become first approved orally administered hypomethylating agent for MDS and CMML in the U.S.

PLYMOUTH MEETING, PA [January 27, 2020] — The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) today announced plans to evaluate futibatinib (TAS-120), a potent and selective inhibitor of the fibroblast growth factor receptor (FGFR). The project will include pre-clinical, translational and clinical trials using futibatinib as monotherapy and in biologically relevant combination regimens for malignancies with FGFR 1-4 aberrations. This project will be the first NCCN research program to study an FGFR inhibitor. Specific research areas will be determined by a group of cancer research experts from NCCN Member Institutions who form a Request for Proposals (RFP) Development Team. The research funding is supported by a $2-million grant from Taiho Oncology.

“We’re excited to help facilitate new research into innovative ways for managing cancer,” said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. “We still have a lot to learn about FGFR signaling and how to optimally target this receptor as a component of cancer therapy. We look forward to the potential new discoveries that may come from these investigations.”

PRINCETON, N.J., January 25, 2020 – Taiho Oncology, Inc. announced today the presentation of a pooled analysis for hematologic adverse events of the global Phase III TAGS and RECOURSE trials evaluating LONSURF^® (trifluridine and tipiracil) in patients with metastatic colorectal cancer (mCRC) and metastatic gastric or gastroesophageal junction cancer (mGC/GEJC), respectively. The company also presented updates on two trials in progress with futibatinib, the Phase III FOENIX-CCA3 study of futibatinib as first-line treatment for patients with advanced cholangiocarcinoma (CCA) harboring FGFR 2 gene rearrangements and a Phase II basket study of futibatinib in patients with advanced solid tumors harboring FGFR genomic aberrations.

PRINCETON, N.J., November 1, 2019 – Recognizing a need for greater awareness and education around gastric cancer, Taiho Oncology, Inc., today announced its support of four leading gastric cancer advocacy organizations in observance of National Gastric Cancer Awareness Month. The company is sponsoring patient and caregiver programs, education and research throughout 2019 on behalf of Debbie’s Dream Foundation, the Gastric Cancer Foundation, Hope for Stomach Cancer and No Stomach For Cancer^®.

PRINCETON, N.J., October 14, 2019 – Taiho Oncology, Inc. announced today that detailed results from the analysis of patients with prior gastrectomy enrolled in the Phase 3 TAS-102 Gastric Study (TAGS) evaluating LONSURF^® (trifluridine and tipiracil) in adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy, were published in the October 10, 2019 issue of JAMA Oncology.

PRINCETON, N.J., June 7, 2019 – Taiho Oncology, Inc. announces that it has assumed commercialization responsibility from Otsuka Pharmaceuticals Co., Ltd., (Otsuka) for the novel fixed-dose combination of cedazuridine and decitabine (ASTX727) and guadecitabine (SGI-110) in the U.S. and Canada, subject to regulatory approvals. Taiho Pharma Canada, Inc., will commercialize these compounds in Canada.

PRINCETON, N.J., June 3, 2019 – Taiho Oncology, Inc. and Servier announced today clinical data with LONSURF^® (trifluridine and tipiracil, TAS-102) in previously treated patients with metastatic gastric cancer (mGC), metastatic gastroesophageal junction adenocarcinoma (mGEJC) and metastatic colorectal cancer (mCRC) were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.

PLYMOUTH MEETING, PA [March 14, 2019] — The National Comprehensive Cancer Network^® (NCCN^®) Oncology Research Program (ORP) has funded three investigators from NCCN Member Institutions through a collaborative scientific research relationship with Taiho Oncology, Inc. to further evaluate the clinical effectiveness and safety of trifluridine and tipiracil (TAS-102) for treatment of various advanced, solid tumors.

PRINCETON, N.J., March 1, 2019 – Taiho Oncology, Inc., in partnership with leading advocacy groups including Colorectal Cancer Alliance, Fight Colorectal Cancer and COLONTOWN^®, today announced its support of a number of prevention and awareness initiatives during National Colorectal Cancer Awareness Month. Colorectal cancer (CRC) is the fourth most commonly diagnosed cancer and the second leading cause of cancer death in the United States, with an estimated 140,250 new cases and 50,630 deaths in 2018.

PRINCETON, N.J., February 25, 2019 – Taiho Oncology, Inc. today announced that the United States Food and Drug Administration (FDA) has approved LONSURF^® as a treatment for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

PRINCETON, N.J., January 17, 2019 – Taiho Oncology, Inc. and Servier announced today that the safety and efficacy in patients with gastrectomy from the global Phase 3 TAGS trial evaluating LONSURF^® in patients with previously treated metastatic gastric cancer (mGC) are consistent with the overall study results published in The Lancet Oncology. These data were highlighted at the ASCO 2019 Gastrointestinal Cancers Symposium (ASCO GI) on Thursday, January 17 during an oral presentation at 2:45 PM PST and during a poster presentation at 11:30 AM-1:00 PM and 5:30 PM-6:30 PM PST. Additional data with LONSURF in metastatic colorectal cancer (mCRC) patients will be presented during a poster session on Saturday, January 19.

PRINCETON, N.J., October 25, 2018 – Taiho Oncology, Inc. today announced that the United States Food and Drug Administration (FDA) has accepted and granted priority review for the supplemental New Drug Application (sNDA) for LONSURF^® (trifluridine/tipiracil, TAS-102) as a treatment for patients with previously treated, advanced or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date of February 24, 2019.

NCCN Awarded $2 Million in Research Funding from Taiho Oncology to Study Trifluridine and Tipiracil in Various Cancers The National Comprehensive Cancer Network’s Oncology Research Program received a grant to investigate effectiveness of trifluridine and tipiracil for treatment of people with colorectal, gastric, and other cancers

PRINCETON, N.J., October 21, 2018 – Taiho Oncology, Inc. (U.S.), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan) and Servier jointly announced today the clinical data from the pivotal Phase III (TAGS) trial evaluating LONSURF^® (trifluridine/tipiracil, TAS-102) versus placebo and best supportive care in patients with heavily pretreated metastatic gastric/gastroesophageal junction (GEJ) cancers who have progressed or are intolerant to previous lines of therapy. The trial met its primary endpoint of prolonged overall survival (OS) and secondary endpoint measures of progression-free survival (PFS), as well as continued to demonstrate LONSURF’s predictable safety and tolerability profile. TAGS, a phase 3, randomised, double-blind study of trifluridine/tipiracil (TAS-102) versus placebo in patients with refractory metastatic gastric cancer (Abstract #LBA25), data were presented by Hendrik-Tobias Arkenau, MD, PhD, from the Sarah Cannon Research Institute (UK) at the ESMO 2018 Congress in Munich, Germany during an oral session on Sunday, October 21 at 11:10 AM CEST. The study results were simultaneously published in The Lancet Oncology.

PRINCETON, N.J., September 28, 2018 – Taiho Oncology, Inc. today announced real-world adherence data for patients with metastatic colorectal cancer (mCRC) who were treated with LONSURF^® (trifluridine and tipiracil) or Stivarga^® (regorafenib).* In this retrospective study, medication adherence was assessed among adult patients with mCRC receiving LONSURF (469) or regorafenib (311). Treatment with LONSURF was associated with significantly higher medication adherence and longer time to discontinuation compared to treatment with regorafenib. These data, from the IQVIA™ Real-World Data Adjudicated Claims-US database, will be presented by Anuj Patel, MD, Dana-Farber Cancer Institute, at the 2018 ASCO Quality of Care Symposium (ASCO QCS) in Phoenix during Poster Session A on Friday, September 28, from 11:30 AM to 1:00 PM and 5:15 PM to 6:15 PM PT.

PRINCETON, N.J., June 21, 2018 – Taiho Oncology, Inc. and Servier today announced clinical data from the pivotal Phase III trial (TAGS) evaluating LONSURF^® (trifluridine and tipiracil, TAS-102) plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated metastatic gastric cancer refractory to standard therapies. This trial met its primary endpoint of overall survival (OS) and secondary endpoint measures of progression-free survival (PFS), and safety and tolerability, as well as quality of life. The data were presented as oral and poster presentations at the ESMO 20th World Congress on Gastrointestinal Cancer 2018 (ESMO-GI) in Barcelona, Spain, June 20 to 23.

PRINCETON, N.J., June 20, 2018 – Taiho Oncology, Inc. today announced a Phase I study to examine the efficacy of TAS-120, an investigational irreversible pan-fibroblast growth factor receptor (FGFR) inhibitor as a potential treatment for patients with advanced solid tumors, including cholangiocarcinoma (CCA), who were previously treated with chemotherapy or other therapies including other FGFR inhibitors. This is a presentation of updated clinical data for TAS-120 in cholangiocarcinoma, a rare cancer with limited treatment options. These data were presented as oral and poster presentations on Wednesday, June 20 at 2:50 PM CEST at the ESMO 20^th World Congress on Gastrointestinal Cancer 2018 (ESMO-GI) in Barcelona, Spain, June 20 to 23.

PRINCETON, N.J., June 14, 2018 – Taiho Oncology, Inc. and Servier today announced that clinical data for LONSURF^® (trifluridine and tipiracil, TAS-102) are being presented at the ESMO 20th World Congress on Gastrointestinal Cancer 2018 (ESMO-GI) in Barcelona, Spain, June 20 to 23. In addition, Taiho announced that data for TAS-120, the Company’s investigational compound being studied for the potential treatment of patients with cholangiocarcinoma, will be presented.

PRINCETON, N.J., June 7, 2018 – Taiho Oncology, Inc. today announced that, in an effort to further support access for patients and their LONSURF^® treatment, the co-pay for all dose strengths of LONSURF has been reduced from $30 to $0 per treatment cycle. The co-pay reduction, which took effect on May 1, 2018, is available to all patients with commercial prescription insurance coverage for LONSURF.

PRINCETON, N.J., May 9, 2018 – Taiho Oncology, Inc. (U.S.), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), and Servier, announced today that the pivotal Phase 3 (TAGS) trial evaluating LONSURF^® (trifluridine and tipiracil) plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated metastatic gastric cancer, met its primary endpoint of prolonged overall survival (OS). These results will be presented at an upcoming medical conference and will be submitted to a peer-reviewed journal for publication.

PRINCETON, N.J., April 13, 2018 – Taiho Oncology, Inc. today announced clinical data for LONSURF^® (trifluridine and tipiracil, TAS-102) for the treatment of patients with advanced gastrointestinal tumors, and two investigational compounds, TAS-120 and TAS-114, both currently in clinical development for the treatment of patients with a variety of advanced solid tumors. These data are being presented at the 109^th Annual Meeting of the American Association for Cancer Research (AACR) in Chicago, April 14 to 18, in McCormick Place South, Exhibit Hall A.

Taiho Oncology Announces Support of Awareness and Research Initiatives to Mark Colorectal Cancer Awareness Month

Taiho Oncology and Servier Present LONSURF^® (trifluridine and tipiracil) Metastatic Colorectal Cancer (mCRC) Data at ASCO 2018 Gastrointestinal Cancers Symposium

Otsuka Signs Statement of Support for Women’s Empowerment Principles

Taiho Oncology Announces Multiple LONSURF^® (trifluridine and tipiracil) Presentations at ASCO 2018 Gastrointestinal Cancers Symposium

Taiho Oncology Names Timothy Whitten President

Health Canada Grants Priority Review Status to trifluridine and tipiracil for Refractory Metastatic Colorectal Cancer

Taiho Pharmaceutical to Participate in Japan Healthcare Venture Summit 2017

Taiho Oncology Inc. Announces Expansion into Canada

Taiho Oncology Announces Multiple Presentations at the ASCO 2016 Annual Meeting

Taiho Oncology, Inc. Announces Comprehensive Access Support Program for LONSURF^® (trifluridine and tipiracil)

Taiho Oncology, Inc. Announces FDA Approval of LONSURF^® (trifluridine and tipiracil) for Refractory Metastatic Colorectal Cancer (mCRC)

Taiho Oncology, Inc. Announces TAS-102 New Drug Application for Refractory Metastatic Colorectal Cancer Accepted for Review by FDA

Taiho Oncology Completes Submission of TAS-102 New Drug Application to the US Food and Drug Administration for the Treatment of Refractory Metastatic Colorectal Cancer

Princeton, NJ – October 20, 2014 – Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), an oral combination anticancer drug under investigation for the treatment of refractory metastatic colorectal cancer (mCRC), and that the Company has initiated a rolling NDA submission to the FDA.

Taiho Pharmaceutical Co., Ltd.(HQ: Tokyo, President and Representative Director: Masayuki Kobayashi, hereinafter “Taiho”), a fully-fledged oncology pharmaceutical company, announced today that the company will be investing US$ 30 million in Remiges BioPharma Fund (hereinafter “Remiges Fund”), a newly formed biotech venture capital fund.

Princeton, NJ – June 28, 2014 – Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), announced today detailed findings from its global Phase III RECOURSE trial of TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), an oral combination anticancer drug.

Princeton, NJ – May 12, 2014 – Taiho Oncology, Inc., a division of Taiho Pharmaceutical Co., Ltd. (Japan), today announced the appointment of Tim Whitten to the position of Senior Vice President and Chief Commercial Officer. The appointment of Mr. Whitten represents the initial step in the transition of the company to a more fully integrated clinical development and commercial entity as it prepares for the potential marketing approval of its lead compound, TAS-102, an oral combination anticancer drug (nonproprietary names: trifluridine and tipiracil hydrochloride). Taiho Oncology, Inc. announced earlier today that TAS-102, in the global Phase III RECOURSE trial, met its primary endpoint of demonstrating improvement in overall survival (OS) in patients with refractory metastatic colorectal cancer (mCRC) whose disease had progressed after approved standard therapies.