On May 18, 2023 Taiho Pharmaceutical Co., Ltd. ("Taiho") reported 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) (Press release, Taiho, MAY 18, 2023, View Source [SID1234631859]).

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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.

About STAR-121 Trial
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

About STAR-221 Trial
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