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.

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.