The NEOTORCH study found that Junshi Biosciences’ toripalimab combined with chemotherapy improved survival outcomes in patients with operable stage II–III non-small cell lung cancer, the company announced on October 27, 2026.
Key Takeaways
- The final analysis followed patients for a median of 48.2 months.
- Toripalimab plus chemotherapy improved event-free and overall survival compared with placebo plus chemotherapy.
- China accepted an application in July 2026 to expand the treatment’s existing lung cancer indication.
NEOTORCH study results
Junshi presented the final analysis at the 2026 European Society for Medical Oncology Congress, with the results simultaneously published in Annals of Oncology. The randomized, double-blind phase 3 trial enrolled 501 patients with resectable stage II–III non-small cell lung cancer.
Patients were assigned to toripalimab or placebo, each with chemotherapy, for three cycles before surgery and one afterward. They then received up to 13 cycles of toripalimab or placebo as maintenance treatment.
The toripalimab group had a lower hazard of death and a lower hazard of an event affecting survival than the placebo group. Median overall survival had not been reached in either group at the final analysis. Junshi said the safety profile remained manageable and that no new safety signals were identified.
| Item | Details |
|---|---|
| Event-free survival | Hazard ratio: 0.52; 95% confidence interval: 0.39–0.68 |
| Overall survival | Hazard ratio: 0.66; 95% confidence interval: 0.49–0.89 |
| Major pathological response | 47% with toripalimab versus 9% with placebo |
| Pathological complete response | 26% with toripalimab versus 1% with placebo |
China application seeks broader indication
China approved toripalimab with platinum-based chemotherapy in December 2023 for perioperative treatment of resectable stage IIIA–IIIB non-small cell lung cancer, based on an earlier NEOTORCH analysis.
The July 2026 application acceptance by China’s National Medical Products Administration covers a proposed expansion to adults with resectable stage II–III disease. Acceptance means the application was taken up for review; it does not mean the broader indication has been approved.
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