China's NMPA accepted a supplemental application expanding toripalimab's perioperative NSCLC indication to stage II-III disease.
The National Medical Products Administration (NMPA) in China has accepted a supplemental application for toripalimab (Loqtorzi) plus platinum-containing chemotherapy as perioperative treatment, followed by toripalimab monotherapy as adjuvant therapy, in adult patients with resectable stage II-III non–small cell lung cancer (NSCLC).1
The application seeks to expand toripalimab's existing NSCLC indication, which currently covers only resectable stage IIIA-IIIB disease, to the broader stage II-III population. The submission is supported by data from the phase 3 NEOTORCH trial (NCT04158440), in which toripalimab plus chemotherapy reduced the risk of disease recurrence, progression, or death by 60% vs chemotherapy alone in patients with stage III NSCLC (HR, 0.40; 95% CI, 0.28-0.57; P < .001).
The NMPA first approved toripalimab plus platinum-containing doublet chemotherapy as perioperative treatment for resectable stage IIIA-IIIB NSCLC in December 2023, based on NEOTORCH's prespecified interim event-free survival (EFS) analysis in the stage III population.¹ That decision made toripalimab the first domestically approved perioperative lung cancer therapy in China and the second worldwide.
In May 2026, NEOTORCH completed its final analysis. The trial's primary end points of EFS and major pathological response (MPR) rate in the stage II-III population, along with MPR rate in the stage III population, met the prespecified efficacy boundary, providing the basis for the current label-expansion filing.
NEOTORCH was a randomized, double-blind, placebo-controlled phase 3 trial. The study enrolled 501 patients with resectable stage II-III NSCLC who received toripalimab at 240 mg or placebo plus platinum-based chemotherapy for 3 preoperative cycles and 1 postoperative cycle, followed by up to 13 cycles of toripalimab or placebo monotherapy as adjuvant therapy.²
Primary end points were investigator-assessed EFS and BIPR-assessed MPR rate in both the stage III and stage II-III populations. Secondary end points included overall survival (OS), IRC-assessed EFS, pathological complete response rate, disease-free survival, and safety.
In July 2026, a post hoc analysis of surgical outcomes among NEOTORCH's stage III population was published in JAMA Surgery.¹,³ Among 314 patients who completed surgery, toripalimab plus chemotherapy lowered the surgery cancellation rate vs chemotherapy alone (17.8% vs 26.7%; P = .03) without increasing perioperative risk or generating new safety signals.¹
The regimen also produced higher rates of tumor downstaging (80.7% vs 50.7%) and lymph node downstaging (67.5% vs 48.6%).¹ Among patients who completed surgery, toripalimab improved EFS vs chemotherapy alone (HR, 0.50; 95% CI, 0.33-0.74; P < .001), and among those who achieved tumor or lymph node downstaging, EFS was similarly improved with toripalimab (HR, 0.45 for both; P = .002 and P = .009, respectively).
