Multicenter phase 3 trial of sintilimab plus chemotherapy for EGFR-mutated nsqNSCLC with disease progression after EGFR TKI therapy

The multicenter phase 3 ORIENT-31 trial in China randomized patients with advanced nonsquamous EGFR-mutated non-small cell lung cancer after progression on EGFR TKI therapy 1:1:1 to sintilimab plus bevacizumab biosimilar IBI305 plus chemotherapy (n=158), sintilimab plus chemotherapy (n=158), or chemotherapy alone (n=160). The first interim analysis had shown better progression-free survival with sintilimab plus IBI305 plus chemotherapy plus chemotherapy over chemotherapy alone. The second interim analysis has now been published, showing that sintilimab plus chemotherapy resulted in better PFS compared to chemotherapy alone, and that the PFS profit with sintilimab plus IBI305 plus chemotherapy over chemotherapy alone was maintained. Safety results were generally consistent with those in the first interim analysis.