In the multicentre, randomized CHOICE-01 study, #Toripalimab with chemotherapy was investigated as first-line treatment in treatment-naïve patients with advanced #NSCLC without EGFR/ALK mutations.

In this Chinese, phase III study, patients (N = 465) were randomized to receive the anti PD-1, toripalimab 240 mg (n = 309) or placebo (n = 156) once every 3 weeks in combination with chemotherapy for 4-6 cycles, followed by the maintenance of toripalimab or placebo once every 3 weeks plus standard care.

Results showed significant improvement of PFS and OS when treated by toripalimab with chemotherapy as a first-line treatment with accepted safety profile. Median PFS was 8.4 months in the toripalimab arm versus 5.6 months with the placebo arm (HR = 0.49; P < .0001). In addition, median OS has not been reached in the toripalimab arm and was 17.1 month in the placebo arm (HR = 0.69; P = .0099). This OS benefit was significantly evident in non-squamous subgroup.