Multicenter phase 3 trial of toripalimab plus chemotherapy for treatment-naïve advanced non-small cell lung cancer

The multicenter phase 3 CHOICE-01 trial investigated the efficacy and safety of toripalimab (anti-PD-1) in combination with chemotherapy as first-line treatment for advanced non-small cell lung cancer (aNSCLC). Patients were randomized to toripalimab or placebo once every three weeks in combination with chemotherapy for 4-6 cycles, followed by toripalimab or placebo maintenance plus standard of care. At the final PFS analysis, PFS was significantly longer in the toripalimab arm than in the placebo arm (HR 0.49; p<0.0001). At the interim OS analysis, the toripalimab arm had a significantly longer OS than the placebo arm (HR 0.69; p=0.0099). The incidence of grade ≥ 3 adverse events was similar between the two arms. Subgroup analysis showed that the OS benefit was mainly driven by the nonsquamous population. The authors conclude that CHOICE-1 results support the use of toripalimab in combination with chemotherapy as a front-line treatment option for advanced NSCLC without EGFR/ALK driver mutations.