Perioperative Toripalimab Plus Chemotherapy Meets Final Phase 3 End Points

A perioperative regimen combining the anti–PD-1 monoclonal antibody toripalimab (Loqtorzi) with platinum-containing doublet chemotherapy has successfully met its primary efficacy boundaries in the final analysis of a multicenter phase 3 trial (NCT04158440). The regimen significantly prolonged event-free survival (EFS) and improved major pathological response (MPR) rates compared with chemotherapy alone in patients with resectable stage II and III non–small cell lung cancer (NSCLC).¹

Shanghai Junshi Biosciences Co Ltd announced the findings from the final analysis of the NEOTORCH trial and stated plans to submit a supplemental new drug application (sNDA) to regulatory authorities. The drug combination is currently approved in China for the perioperative treatment of resectable stage III NSCLC; the upcoming sNDA seeks to expand this indication to include patients with stage II disease.

NEOTORCH Study Background

The randomized, double-blind, placebo-controlled phase 3 NEOTORCH trial enrolled 501 patients with resectable stage II or III NSCLC. Patients were randomized to receive either perioperative toripalimab or a placebo in combination with platinum-doublet chemotherapy. The primary end points were investigator-assessed EFS in the stage III and stage II–III cohorts, alongside MPR rates assessed by a blind independent pathology review committee (BIPR). Secondary end points included overall survival (OS), pathological complete remission (pCR) rate, disease-free survival, and safety.

Data from the trial demonstrated a substantial clinical benefit when toripalimab was added to the standard perioperative care framework.

Previous Data Reports

According to previously disclosed interim data published in JAMA, the median EFS was not reached in the toripalimab cohort compared with 15.1 months in the chemotherapy-alone group.² This translated to a 60% reduction in the risk of disease recurrence, progression, or death (HR, 0.40; 95% CI, 0.28-0.57; P <.001).

Pathological outcomes also showed notable disparities between the cohorts. The addition of toripalimab resulted in a nearly 25-fold increase in the pCR rate (24.8% vs 1.0%) and an approximate 6-fold increase in the MPR rate (48.5% vs 8.4%). Additionally, a descriptive analysis of OS revealed a positive trend favoring the immunotherapy-containing arm (HR, 0.62; 95% CI, 0.38-1.00). The final analysis confirmed that the primary end points of EFS and MPR rate in the overall stage II–III population, as well as the MPR rate in the stage III cohort, crossed the predefined statistical boundaries for efficacy.

Lung cancer remains the leading cause of oncological mortality globally. In China alone, approximately 1.06 million new cases and 730,000 deaths were documented in 2022.³ Although 20% to 25% of patients present with surgically resectable disease at initial diagnosis, historical recurrence rates following radical resection remain high, ranging from 30% to 55%. Standard neoadjuvant or adjuvant chemotherapy regimens offer modest survival benefits, typically improving 5-year survival rates by roughly 5%.

Immune checkpoint inhibition targeting the PD-1/PD-L1 pathway has increasingly shifted the therapeutic paradigm in early-stage NSCLC by mitigating immune evasion and promoting long-term disease control. Toripalimab is designed to block PD-1 interactions with its ligands, PD-L1 and PD-L2, while promoting PD-1 receptor internalization. The detailed final data from the NEOTORCH analysis are scheduled to be presented at an upcoming international academic oncology conference.

REFERENCES

1. Junshi Biosciences Announces Primary Endpoints Met in Final Analysis of Phase 3 Study for Perioperative Toripalimab plus Chemotherapy for Resectable Stage II-III NSCLC. News release. Junshi Biosciences. May 26, 2026. Accessed May 27, 2026. https://tinyurl.com/ytwxcb6x

2. Lu S, Zhang W, Wu L, et al. Perioperative toripalimab plus chemotherapy for patients with resectable stage III non-small cell lung cancer: the NEOTORCH randomized clinical trial. JAMA. 2024;331(3):201-211. doi:10.1001/jama.2023.24735

3. International Agency for Research on Cancer. Cancer Today: China Fact Sheet. World Health Organization; 2022. Accessed May 27, 2026. https://tinyurl.com/4nybwaf8