Multicenter randomized trial of addition of toripalimab to perioperative chemotherapy for stage III resectable non-small cell lung cancer

Neoadjuvant and adjuvant immunotherapy have improved outcomes of patients with early stage non-small cell lung cancer; however, the optimal combination of checkpoint inhibition with chemotherapy remains unknown. The randomized Neotorch trial, at 50 centers in China, evaluated addition of toripalimab (240 mg) or placebo every 3 weeks, combined with platinum-based chemotherapy for 3 cycles before surgery and on cycle after surgery, followed by toripalimab (240 mg) or placebo every 3 week for up to 13 cycles. The median event-free survival (coprimary outcome) was not reached in the toripalimab group and was 15.1 months in the placebo group (HR 0.40; p<0.001). The major pathological response rate (coprimary end point) was 48.5% versus 8.4% (p<0.001). The pathological complete response rate (secondary outcome) was 24.8% versus 1.0%. The incidence of adverse events of grade 3 or higer, grade 5, or resulting in discontinuation was not significantly different between the groups. The author conclude that among patients with resectable stage III NSCLC, addition of toripalimab to perioperative chemotherapy was associated with significant improvement of EFS and MPR, with a manageable safety profile.