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David S. Ettinger, MD, FACP, FCCP
David S. Ettinger, MD, FACP, FCCP
Posted: Tuesday, April 25, 2023
Adding the anti–PD-1 monoclonal antibody toripalimab to perioperative platinum-doublet chemotherapy yielded statistically significant improvements in event-free survival (P < .0001) for patients with stage III non–small cell lung cancer (NSCLC), according to the results of a planned interim analysis of the phase III Neotorch trial. In their work, presented in the ASCO Plenary Series (Abstract 425126), Shun Lu, MD, PhD, of Shanghai Jiao Tong University, China, and colleagues also noted that toripalimab had a manageable safety profile.
Neotorch is evaluating the efficacy and safety of perioperative chemotherapy (every 3 weeks for three cycles before surgery and one cycle after surgery) plus toripalimab (240 mg) or placebo in 404 patients with resectable nonsquamous NSCLC and no EGFR/ALK alterations. Those in the treatment arm also received toripalimab maintenance every 3 weeks for 13 cycles (vs. placebo in the other arm). Patients were randomly assigned on a 1:1 basis and were well matched for stratification variables, including disease stage, histopathologic subtype, PD-L1 expression, and surgical procedure.
With a median follow-up of 18.3 months, median event-free survival was not reached in the toripalimab arm; it was 15.1 months in the placebo arm. “A consistent effect on event-free survival, favoring toripalimab, was observed in all subgroups,” noted Dr. Lu and co-investigators. The major pathologic response rate, a primary endpoint along with event-free survival, was also higher in the toripalimab arm (48.5% vs. 8.4%).
The incidence of grade ≥ 3 adverse events (63.4% vs. 54.0%), fatal adverse events related to toripalimab/placebo (0.5% vs. 0%), and adverse events leading to discontinuation of toripalimab/placebo (9.4% vs. 7.4%) were all comparable between the two arms. However, the incidence of immune-related adverse events (42.1% vs. 22.8%) was more frequent with toripalimab.
Overall survival results showed a trend favoring toripalimab. Patients will continue to be followed for overall survival, which is among the trial’s secondary endpoints.
Disclosure: The study authors’ disclosure information can be found at coi.asco.org
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