News Releases

Taiho Pharmaceutical Co., Ltd. (“Taiho”) announced today that it has entered into a Clinical Trial Agreement with Arcus Biosciences, Inc. (“Arcus”) and Gilead Sciences, Inc. (“Gilead”) related to the Arcus programs which Taiho had previously obtained rights to develop and commercialize in Japan and certain other territories in Asia (excluding China).

Based on this agreement, Taiho will be eligible to participate in certain global clinical trials conducted not only by Arcus but also by Gilead for programs which Taiho has exercised its option rights under the Taiho and Arcus Option and License Agreement contracted in 2017. These optioned programs currently are the anti-TIGIT program (domvanalimab and AB308), the anti-PD-1 monoclonal antibody program (zimberelimab), and the adenosine receptor antagonist program (etrumadenant). The Clinical Trial Agreement is expected to further accelerate the development of these Arcus in-licensed products in Japan.

Taiho will participate in two global phase 3 clinical trials, STAR-121 trial in non-small cell lung cancer, and STAR-221 trial in upper gastrointestinal tract cancer, both of which are expected to be initiated in Japan during 2023.

Taiho looks forward to working closely with Arcus and Gilead under this clinical trial agreement, and together advance the development of these investigational drugs and innovative treatments.

STAR-121 is a randomized, open-label, global Phase 3 trial consisting of 1) zimberelimab and domvanalimab plus chemotherapy arm, 2) pembrolizumab plus chemotherapy arm, and 3) zimberelimab plus chemotherapy arm as first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) with no Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK) mutations or other actionable genomic alteration.

The primary endpoints of the study are progression-free survival (PFS) and overall survival (OS).

STAR-121Trial: A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy for the First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations

STAR-221 is a randomized, open-label, global Phase 3 trial consisting of 1) domvanalimab and zimberelimab plus chemotherapy arm and 2) nivolumab plus chemotherapy arm in patients with previously untreated locally advanced unresectable or metastatic adenocarcinomas of gastric cancer, gastroesophageal junction cancer, and the esophagus. The primary endpoint of the study is overall survival (OS).

STAR-221 Trial: A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma

Based on the option and license agreement that Taiho and Arcus entered into in 2017, Taiho has obtained exclusive development and commercialization rights to etrumadenant (development code: AB928), the adenosine receptor antagonist program in 2018, zimberelimab (development code: AB122), the anti-PD-1 program in 2019, and domvanalimab (development code: AB154) and AB308, both the anti-TIGIT program in 2021, in Japan and certain other territories in Asia (excluding China).

For territories outside Japan and Asia, Gilead obtained rights to co-commercialize with Arcus in the U.S., and exclusive rights to develop and commercialize outside the U.S.

Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines for people with cancer. In partnership with industry partners, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has expedited the development of six investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, the adenosine axis (CD73 and dual A2a/A2b receptor) and most recently, HIF-2a. For more information about Arcus Biosciences’ clinical and pre-clinical programs, please visit www.arcusbio.com or follow us on Twitter.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd., is an R&D-driven specialty pharma company with a focus on oncology. Taiho Pharmaceutical also has development programs in allergy and immunology, urology and consumer healthcare products. Our corporate philosophy the form of a pledge: “We strive to improve human health and contribute to a society enriched by smiles.”

For more information about Taiho Pharmaceutical, please visit: https://www.taiho.co.jp/en/.