Press Releases

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.