Multicenter phase 3 study of sintilimab plus IBI305 and chemotherapy for EGFR-mutated nsqNSCLC after progression on EGFR TKI

Despite high initial response rates, almost all NSCLC patients eventually develop treatment resistance to EGFR tyrosine kinase inhibitors. The phase 3 ORIENT-31 trial, at 52 centers in China, evaluated the combination of sintilimab (anti-PD-1), IBI305 (bevacizumab biosimilar) and cisplatin-pemetrexed chemotherapy for advanced EGFR-mutated NSCLC after progression on EGFR-TKI therapy. Patients were randomized to sintilimab plus IBI305 plus chemotherapy (arm A), sintilimab plus chemotherapy (arm B), or chemotherapy alone (arm C). Interim analysis of the trial found that progression-free survival was superior for arm A versus arm C. The treatment was generally well tolerated.