Domvanalimab is currently being analysed in a Phase III study for upper GI adenocarcinomas. Credit: aslysun / Shutterstock.

Gilead Sciences and Arcus Biosciences have reported initial assessment data from Arm A1 of the EDGE-Gastric clinical trial of domvanalimab in combination with zimberelimab and chemotherapy.

The international, multi-arm Phase II study is designed to assess the efficacy and safety of various combinations of domvanalimab and zimberelimab for treating upper gastrointestinal (GI) cancers.

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It enrolled individuals with locally advanced unresectable or metastatic gastric (G), gastroesophageal junction (GEJ) or oesophageal (E) adenocarcinoma. 

Arm A1 included treatment-naïve G/GEJ/E adenocarcinoma patients, who were given an intravenous dose of domvanalimab every four weeks along with 80mg of zimberelimab IV Q4W and FOLFOX (oxaliplatin 85mg/m² IV, leucovorin 400mg/m² IV, fluorouracil 400mg/m² IV bolus + 2,400mg/m² continuous 46-48-hour IV infusion) every two weeks.

According to the findings, the combination treatment offered encouraging overall response rate (ORR) and six-month progression-free survival (PFS). 

Following treatment with the domvanalimab regimen, subjects with PD-L1-high tumours had an ORR of 80%, while a 46% ORR was reported in PD-L1-low tumour patients.

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The six-month PFS rate was 93% and 68% for subjects with PD-L1-high and PD-L1-low tumours respectively. 

The domvanalimab regimen was found to be well-tolerated with a safety profile in line with those of anti-PD-1 plus chemotherapy in this setting.

Domvanalimab is a Fc-silent anti-TIGIT antibody currently being analysed in a Phase III study for upper GI adenocarcinomas.

EDGE-Gastric study principal investigator Yelena Janjigian said: “The preliminary data from the EDGE-Gastric study underscore the potential role of dual anti-TIGIT and anti-PD-1-containing regimen in the treatment of gastroesophageal cancer where front-line chemotherapy with anti-PD-1 blockade is currently the standard.

 “These early data are encouraging and indicate the potential for the anti-TIGIT, domvanalimab-based therapy to improve upon anti-PD-1 and chemotherapy in this setting, with a similar safety profile to anti-PD-1 and chemotherapy.”

In September 2023, Gilead Sciences reported findings from the Phase II EVOKE-02 study of Trodelvy for metastatic non-small cell lung cancer.