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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 7 days ago
- 2 min read
12/12/2025
Arcus and Gilead have discontinued the Phase 3 STAR-221 trial of their TIGIT regimen in gastric and esophageal cancers (Ref)
The Phase 3 STAR-221 trial of Arcus Biosciences and Gilead's domvanalimab (anti-TIGIT) + zimberelimab (anti-PD-1) + chemotherapy vs nivolumab + chemotherapy as a first-line treatment for advanced gastric and esophageal cancers has been discontinued due to futility.
The decision is based on the recommendation from the Independent Data Monitoring Committee (IDMC) following its review of data from an event-driven, pre-specified interim analysis of OS
To note, the STAR-221 and the Phase 2 EDGE-Gastric studies will be discontinued, and Arcus and Gilead are communicating with investigators to determine appropriate next steps for patients in the study in addition to conducting a detailed analysis to better understand these results.
Johnson & Johnson's AKEEGA received FDA approval for BRCA2-mutated CSPC (Ref)
The US FDA granted approval to Johnson & Johnson's sNDA for niraparib and abiraterone acetate dual-action tablet (AKEEGA; PARB inhibition and novel hormonal therapy) + prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC).
The approval is based on positive results from the Phase 3 AMPLITUDE (NCT04497844) trial
Bradley McGregor, M.D., Director of Clinical Research for the Lank Center of Genitourinary Oncology at Dana-Farber Cancer Institute: “There remains an urgent need for novel therapies for patients with BRCA2-mutated mCSPC, who face significantly faster disease progression and often shorter survival compared to those without the mutation. AMPLITUDE is the first study to show that this precision medicine combination of a PARP inhibitor with an androgen receptor pathway inhibitor delays both radiographic and symptomatic disease progression.”