Journal Publication

Toripalimab surgery data show fewer canceled operations in NEOTORCH

A post hoc analysis of the Neotorch trial ties perioperative toripalimab to lower surgery-cancellation rates and deeper tumor downstaging, both linked to longer event-free survival.

By AppliedXLJuly 15, 2026Trial NCT04158440

Executive Summary

A post hoc analysis of a randomized, placebo-controlled Phase 3 lung cancer trial examined how a perioperative checkpoint-inhibitor regimen affected surgery itself, not only tumor response.
Patients on the active regimen were less likely to have their surgery canceled and were more likely to show tumor and lymph node downstaging at the time of resection.
Downstaging in the treated arm tracked with longer event-free survival, and tracked with better survival than the same downstaging achieved on placebo, suggesting the surgical and pathological changes are not just cosmetic markers.
Because the analysis was not prespecified as the trial's primary comparison, the association between surgical outcomes and survival needs confirmation beyond this single dataset before it can guide clinical decisions on its own.

The finding

The analysis, published as a post hoc reading of the Neotorch randomized trial, examined surgical outcomes in patients with resectable stage III non-small cell lung cancer (NSCLC) who received toripalimab, a PD-1 checkpoint inhibitor, plus platinum-based chemotherapy before and after surgery, compared with placebo plus chemotherapy. Among 404 patients enrolled who reached the surgical stage, 314 underwent resection, 166 on toripalimab and 148 on placebo. The share of patients whose surgery was canceled was 17.8% in the toripalimab group versus 26.7% on placebo (P =.03). Surgical

How it was done

Neotorch is a multicenter, double-blind, placebo-controlled Phase 3 trial (NCT04158440) that enrolled patients with resectable stage IIIA or IIIB NSCLC at 50 centers in China, randomizing them 1:1 to toripalimab (240 mg) or placebo, each combined with platinum-based chemotherapy for three cycles before surgery and one cycle after, followed by 13 cycles of single-agent maintenance therapy. This post hoc analysis, drawing on data analyzed between July 2024 and March 2026, evaluated perioperative complications, tumor and lymph node downstaging, and their association with event-free survival (EFS) among the 314 patients who went to surgery, with a median follow-up of 18.3 months. Surgical

The pathological result

Rates of postsurgical tumor downstaging were 80.7% with toripalimab versus 50.7% with placebo (P <.001), and lymph node downstaging occurred in 67.5% versus 48.6% of patients (P =.001). Surgical technique measures, including the proportions of minimally invasive procedures, R0 (margin-negative) resections, and lobectomies, were higher with toripalimab, and surgical complication rates were similar between the two arms. Surgical

The survival link

Tumor and lymph node downstaging in the toripalimab group were both associated with longer EFS than no downstaging (median EFS not estimable versus 17.5 months, P =.004, for tumor; not estimable versus 19.2 months, P =.001, for lymph nodes). Downstaging on toripalimab also tracked with longer EFS than the same downstaging achieved on placebo (not estimable versus 22.0 months, P =.002, for tumor; not estimable versus not estimable, P =.009, for lymph nodes), indicating the pathological response carried more prognostic weight when it occurred under active treatment. Surgical

The trial context

Neotorch's registered primary endpoints are event-free survival and major pathological response rate in the stage II-III and stage III populations, evaluated up to three years and up to seven weeks after neoadjuvant therapy, respectively. In a separate final analysis, the trial met its primary endpoints, with toripalimab improving EFS (hazard ratio 0.40, 95% CI 0.28-0.57, P<0.001) and increasing major pathological response (48.5% versus 8.4%) and pathological complete response (24.8% versus 1.0%). This post hoc analysis adds surgical-level detail to that already-established result rather than testing a new primary hypothesis. NCT04158440

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