Multicenter phase 2 trial of second-line FOLFIRI plus durvalumab with or without tremelimumab for advanced G/GEJ adenocarcinoma

Efficacy of second-line chemotherapy in advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma is limited. The randomized noncomparative phase 2 DURIGAST trial, at 37 centers in France, evaluated second-line FOLFIRI plus durvalumab (anti-PD-L1) with or without tremelimumab (anti-CTLA-4) for G/GEJ adenocarcinoma after progression on first-line platinum-based chemotherapy. In this trial including 96 patients, FOLFIRI plus durvalumab with or without tremelimumab was associated with an acceptable safety profile. However, the primary end point, progression-free survival at 4 months, was not met despite a subgroup of patients with durable disease control. The authors conclude that these findings sugges that for patients with advanced G/GEJ adenocarcinoma, second-line combinations of chemotherapy and immune checkpoint inhibitors should be evaluated in a selected subgroup of patients with favorable biomarkers that remain to be identified (visual abstract).