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Zev A. Wainberg, MD, MSc, discusses data from the EDGE-Gastric trial of domvanalimab plus zimberelimab and FOLFOX in first-line, metastatic gastric cancer.
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“The median PFS in this small cohort was 12.9 months…That’s a signal that warrants further investigation.”
Zev A. Wainberg, MD, MSc, a professor of medicine in the Department of Medicine at UCLA and co-director of the UCLA GI Oncology Program, discussed findings from the phase 2 EDGE-Gastric trial (NCT05329766), which is investigating the efficacy and safety of domvanalimab plus zimberelimab (Sepalizumab) and FOLFOX (fluorouracil, leucovorin, and oxaliplatin) in patients with first-line, locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma.
The largest dataset showing the activity of domvanalimab plus zimberelimab and FOLFOX in patients with newly diagnosed gastric/GEJ/esophageal cancer comes from the EDGE-Gastric trial, Wainberg began. Among 41 evaluable patients in the overall population, where patients were allowed to enroll regardless of PD-L1 status, the overall response rate (ORR) was 59% (95% CI, 42%-74%), including complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) rates of 7%, 51%, 34%, and 5%, respectively. The median duration of response was 12.4 months (95% CI, 9.9-not evaluable). The median progression-free survival (PFS) was 12.9 months (95% CI, 9.8-13.8), and the 12-month PFS rate was 58% (95% CI, 42%-74%).
In the cohort of patients with a PD-L1 tumor activity positivity (TAP) score of at least 5% (n = 16), the ORR rate was 69% (95% CI, 41%-89%), including a CR rate of 6% and a PR rate of 63%; the SD rate was 31%. In the population of patients with a TAP score of less than 5%, the ORR rate was 50% (95% CI, 29%-71%). The respective CR, PR, SD, and PD rates in this population were 4%, 46%, 38%, and 8%.
Overall, these efficacy signals support the continued investigation of domvanalimab plus zimberelimab and chemotherapy in patients with gastric, GEJ, and esophageal cancer, according to Wainberg. The phase 3 STAR-221 study (NCT05568095) is evaluating domvanalimab plus zimberelimab and FOLFOX or CAPOX (capecitabine and oxaliplatin) compared with nivolumab plus FOLFOX or CAPOX in patients with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma.
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