Junshi Biosciences NEOTORCH final data show 34% OS gain in NSCLC
Junshi Biosciences has presented the final analysis of its Phase 3 NEOTORCH study at the ESMO Congress 2026, showing that perioperative toripalimab plus chemotherapy delivered statistically significant and durable gains in both event-free survival and overall survival in patients with resectable stage II-III non-small cell lung cancer. The results were simultaneously published in the Annals of Oncology.
The randomised, double-blind, placebo-controlled trial enrolled 501 patients, who received toripalimab (240 mg every three weeks) or placebo alongside three cycles of chemotherapy before surgery and one cycle after, followed by up to 13 maintenance cycles. With a median follow-up of 48.2 months, the toripalimab arm demonstrated a hazard ratio for event-free survival of 0.52 (95% CI: 0.39–0.68; P less than 0.0001), representing a 48% reduction in the risk of recurrence, progression, or death. Median EFS was not reached in the toripalimab arm, compared with 20.2 months for placebo.
Pathological and survival outcomes
Pathological response rates reinforced the EFS signal. The blinded independent pathologic review reported a major pathological response rate of 47% in the toripalimab arm versus 9% with placebo, and a pathologic complete response rate of 26% versus 1%. Both comparisons were highly statistically significant.
On overall survival, toripalimab reduced the risk of death by 34% relative to placebo (HR=0.66; 95% CI: 0.49–0.89; P=0.0072), with median OS not reached in either arm at the time of analysis. The EFS benefit was consistent across subgroups including disease stage, PD-L1 expression status, histology, and age. The safety profile was described as manageable and consistent with earlier analyses, with no new signals identified.
These final-analysis data build on interim results presented at ASCO 2023 and published in JAMA in January 2024, which had already supported China's NMPA approval in December 2023 for perioperative toripalimab in resectable stage IIIA-IIIB NSCLC. In July 2026, the NMPA accepted a supplemental application to extend the indication to the broader stage II-III population covered by the full study.
Market context and competitive landscape
Perioperative PD-1 and PD-L1 checkpoint blockade in resectable NSCLC has become one of the most contested spaces in oncology drug development. Toripalimab joins a field that includes AstraZeneca's durvalumab, which has approval in the US and EU for resectable NSCLC following the AEGEAN trial, and Roche's atezolizumab in the neoadjuvant setting. Bristol Myers Squibb's nivolumab has also secured perioperative approvals on the back of CheckMate 77T. Junshi's competitive positioning rests partly on its existing NMPA reimbursement footprint in China, where toripalimab is included in the National Reimbursement Drug List across 12 indications, and partly on an approval base that now spans more than 50 countries including the US, EU, and UK.
For Western markets, the key outstanding question is whether the NEOTORCH dataset, conducted predominantly in Chinese centres, will support further label expansions or partnership discussions with larger multinationals. The four-year follow-up data and the magnitude of the pCR and OS signals are likely to attract attention, but cross-trial comparisons remain difficult given differences in patient populations, chemotherapy backbones, and staging criteria across the perioperative checkpoint inhibitor programmes. Clinicians and investors will watch for subgroup analyses and any quality-of-life data to emerge from the full publication.