Phase III Trial Supports Use of Toripalimab Plus Chemotherapy in Stage III NSCLC

By: Amy MacDonald, MS
Posted: Thursday, March 7, 2024

Shun Lu, MD, of Shanghai Jiao Tong University, and colleagues evaluated the perioperative addition of the anti–PD-1 monoclonal antibody toripalimab to established chemotherapy for patients with advanced resectable non–small cell lung cancer (NSCLC). Interim findings from the Neotorch trial, published in JAMA, support the benefit of this regimen for both of the trial’s primary endpoints—event-free survival and major pathologic —with a “manageable” safety profile.

“There were higher rates of curative surgery in the toripalimab group. Furthermore, the combination treatment did not affect the R0 resection rate or increase the incidence of surgery-related adverse events,” the investigators stated.

This double-blind, placebo-controlled, phase III trial enrolled 501 patients with advanced NSCLC from 50 hospitals in China from March 2020 to June 2023. Patients were randomly assigned to receive toripalimab or placebo (once every 3 weeks combined with chemotherapy for three cycles before surgery and one cycle after surgery), followed by toripalimab or placebo once every 3 weeks.

Of these patients, 404 with stage III cancer were included in the interim analysis. Analysis was statistically preplanned to trigger when 139 patients reached event-free survival.

Event-free survival rates were found to be superior in patients receiving tripolimab, both at the 1-year mark (84.4% with toripalimab vs 57.0% with placebo) and the 2-year mark (64.7% vs 38.7%), respectively. The major pathologic response rate (another primary outcome) was 48.5% (95% confidence interval [CI] = 41.4%–55.6%) with toripalimab compared with 8.4% (95% CI = 5.0%–13.1%) without it. Of note, the statistical difference between these groups was 40.2% (95% CI = 32.2%–48.1%, P < .001). The authors stated that the incidence of adverse events was similar between the treatment and placebo groups.

They concluded that the addition of toripalimab to preoperative chemotherapy should be considered in patients with resectable stage III NSCLC.

Disclosure: For full disclosures of the study authors, visit jamanetwork.com.

JAMA