Shanghai Junshi Biosciences Co., Ltd. (JUNSHI BIO) reported that its randomized, double-blind, placebo-controlled, multi-center Phase III NEOTORCH study (NCT04158440) evaluating toripalimab (TUOYI®, JS001) plus platinum-based chemotherapy as perioperative treatment for resectable stage II-III non-small cell lung cancer (NSCLC) met all primary efficacy endpoints at final analysis. Specifically, toripalimab demonstrated statistically significant improvements in event-free survival (EFS) and major pathological response (MPR) in the overall stage II-III cohort, as well as MPR in the stage III subgroup, versus chemotherapy alone.
The company will submit a supplemental new drug application to expand the existing Chinese approval—which currently covers perioperative treatment for resectable stage III NSCLC—to include patients with resectable stage II disease. Toripalimab is already approved for 13 indications in mainland China, with 12 listed on the National Reimbursement Drug List. Internationally, the PD-1 monoclonal antibody has marketing authorizations in more than 40 jurisdictions, including the United States, European Union, United Kingdom, Australia, India and Singapore.
Interim NEOTORCH data released earlier showed toripalimab plus chemotherapy reduced the risk of disease recurrence, progression or death by 60% (hazard ratio 0.40; 95% CI: 0.28–0.57) and extended median EFS beyond 15.1 months, which had been observed with chemotherapy alone. The combination also lifted the pathological complete response rate to 24.80%, compared with 1.00% for chemotherapy, and increased the MPR rate to 48.50% versus 8.40%. Overall survival trended favorably (HR = 0.62; 95% CI: 0.38–1.00), and these results were published in JAMA in January 2024.
Toripalimab, the first domestically approved PD-1 inhibitor in China and recipient of the Chinese Patent Gold Award, continues to expand its clinical footprint through more than forty global studies across over fifteen cancer indications. Earlier, Chinese regulators approved toripalimab’s use with chemotherapy as the country’s first perioperative therapy for resectable stage IIIA–IIIB NSCLC, a regimen that has since received top-tier recommendation in the 2024 CSCO NSCLC guidelines.
JUNSHI BIO cautions that drug development involves substantial risk and uncertainty and advises investors to consider these factors when making investment decisions. The company will disclose further updates in accordance with regulatory requirements.
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