News Center

• Perioperative toripalimab plus chemotherapy demonstrated significant and durable improvements in event-free survival and overall survival in patients with resectable stage II-III non-small cell lung cancer.

SHANGHAI, China, October 27, 2026 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the final analysis results from the Phase 3 NEOTORCH study (NCT04158440) were presented during an oral session at the 2026 European Society for Medical Oncology (ESMO) Congress (Abstract No. LBA64) and simultaneously published in Annals of Oncology. Professor Shun LU and Professor Ziming LI from Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine served as the corresponding author and first author of the publication, respectively.

NEOTORCH (NCT04158440) is a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating perioperative toripalimab in combination with chemotherapy in patients with resectable stage II-III non-small cell lung cancer (NSCLC). A total of 501 patients were randomized 1:1 to receive toripalimab (240 mg, Q3W) or placebo, each in combination with chemotherapy for three cycles before surgery and one cycle after surgery, followed by up to 13 cycles of toripalimab or placebo maintenance therapy.

With a median follow-up of 48.2 months, perioperative toripalimab in combination with chemotherapy demonstrated significant and durable improvements in event-free survival (EFS), major pathological response (MPR), and overall survival (OS) compared with placebo plus chemotherapy in patients with resectable stage II-III NSCLC. The safety profile was manageable, with no new safety signals identified.

Key Results

At the prespecified final analysis, with a median follow-up of 48.2 months:

• EFS: Toripalimab plus chemotherapy significantly prolonged EFS compared with placebo plus chemotherapy (HR=0.52; 95% CI: 0.39-0.68; P<0.0001), representing a 48% reduction in the risk of disease recurrence, progression, or death. Median investigator-assessed EFS was not reached in the toripalimab arm versus 20.2 months in the placebo arm. The EFS benefit was generally consistent across key patient subgroups, including disease stage, PD-L1 expression, histology, and age.
• Pathological response: The blinded independent pathologic review (BIPR)-assessed MPR rate was 47% versus 9% in the toripalimab and placebo arms, respectively, and the pathologic complete response (pCR) rate was 26% versus 1% (both P<0.0001).
• OS: Toripalimab plus chemotherapy significantly improved OS versus placebo plus chemotherapy (HR=0.66; 95% CI: 0.49-0.89; P=0.0072), corresponding to a 34% reduction in the risk of death. Median OS was not reached in either treatment arm.
• Safety: The safety profile remained manageable and consistent with prior analyses, with no new safety signals identified.

The prespecified interim analysis of NEOTORCH in patients with resectable stage III NSCLC previously demonstrated statistically significant improvements in EFS and MPR. The results were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and published in JAMA in January 2024.

Based on these interim results, in December 2023, China’s National Medical Products Administration (NMPA) approved toripalimab in combination with platinum-based chemotherapy for the perioperative treatment of patients with resectable stage IIIA-IIIB NSCLC. In July 2026, the NMPA accepted a supplemental application to expand the indication to patients with resectable stage II-III NSCLC, based on the final analysis of the overall study population.