The global STAR-221 trial enrolled nearly 1,050 subjects with upper GI cancers. Credit: aipicte/Shutterstock.

Arcus Biosciences has concluded the subject enrolment in the Phase III STAR-221 clinical trial of domvanalimab plus zimberelimab in combination with chemotherapy for patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or oesophageal adenocarcinoma (upper GI cancers).

Domvanalimab is the Fc-silent anti-TIGIT antibody while zimberelimab is the anti-PD-1 monoclonal antibody. Both assets are in the investigational stage.

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The global STAR-221 trial, conducted in collaboration with Gilead Sciences, has enrolled nearly 1,050 subjects.

Overall survival in programmed death-ligand 1 (PD-L1)-high tumours and in the intent-to-treat population, which includes all PD-L1 levels, are the trial’s primary endpoints.

Secondary endpoints of the study comprise progression-free survival, objective response rate and duration of response.

The participants were randomised 1:1 between two arms, with one group receiving a combination of domvanalimab, zimberelimab and chemotherapy, while the other arm was assessed with nivolumab and chemotherapy.

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The results from arm A1 of the Phase II EDGE-Gastric study, which evaluated the same regimen in the same setting as the STAR-221 Phase III study, showed that people who received the domvanalimab plus zimberelimab and chemotherapy regimen had a median progression-free survival of 12.9 months.

Arcus Biosciences chief medical officer Dimitry Nuyten said: “STAR-221 completed enrolment well ahead of schedule, driven by significant interest from the global medical community in the potential for an anti-TIGIT-based regimen to address the high unmet need in this setting.

“Domvanalimab is the first and only anti-TIGIT antibody to be studied in a Phase 3 trial in upper gastrointestinal adenocarcinoma. We are now preparing for the readout and look forward to the potential opportunity to make a meaningful difference for patients with this disease.”

In August last year, the companies deprioritised the development of etrumadenant in castrate-resistant prostate cancer after the drug showed an underwhelming response on radiographic progression-free survival in an ongoing trial.