Shanghai Junshi Biosciences Co., Ltd. and Coherus BioSciences, Inc. announced the publication of toripalimab plus chemotherapy for patients with treatment-naïve advanced non-small cell lung cancer: a multi-center randomized phase 3 trial (CHOICE-01) in the Journal of Clinical Oncology. Toripalimab in combination with chemotherapy was associated with significant improvements in progression-free survival (PFS) (primary endpoint) and overall survival (OS) (secondary endpoint) compared with chemotherapy alone in patients with advanced non-small cell lung cancer ("NSCLC") without epidermal growth factor receptor (EGFR)/anaplastic lymphoma kinase (ALK) mutations, regardless of PD-L1 expression. No new safety signals were observed with toripalimab in this study.

A total of 465 patients with treatment-naïve, advanced NSCLC without EGFR/ALK mutations were randomized 2:1 to receive toripalimab 240 mg (n=309, “the toripalimab arm”) or placebo (n=156, “the placebo arm”) in combination with chemotherapy for 4-6 cycles, followed by the maintenance of toripalimab or placebo plus standard care. PFS was the primary endpoint. Statistically significant improvements in both PFS and OS were detected in the toripalimab arm compared with the placebo arm, with similar rates of adverse events (AEs).

At the final analysis, PFS was significantly longer in the toripalimab arm than in the placebo arm (median PFS 8.4 vs 5.6 months; 1-year PFS rates 36.7% vs 17.2%). At the interim OS analysis, the toripalimab arm had a significantly longer OS than the placebo arm (median OS not reached vs 17.1 months). OS rates at 2 years were 51.2% vs 33.9%, in the two arms. The incidence of Grade > 3 AEs was similar between the two arms (78.6% vs 82.1%).