(RTTNews) - Junshi Biosciences Co., Ltd (1877.HK) announced that its Phase 3 NEOTORCH study of Toripalimab combined with platinum-based chemotherapy in patients with resectable stage II-III non-small cell lung cancer met its primary endpoints in the final analysis.
Landmark Results in Perioperative Treatment
The trial achieved event-free survival and major pathological response (MPR) endpoints in stage II-III patients, as well as MPR in stage III patients, crossing the pre-defined efficacy boundary.
Toripalimab plus chemotherapy showed significant improvement in EFS compared to chemotherapy alone, reducing recurrence, progression, or death risk by 60%. The regimen also boosted complete pathological remission rates to 24.8% versus 1.0% and MPR to 48.5% versus 8.4%.
Expanding Regulatory Pathways
Junshi plans to submit a supplemental new drug application (sNDA) to broaden approval from stage III to stage II-III NSCLC perioperative treatment. Toripalimab is already approved in China for stage III NSCLC perioperative use, marking the first domestic approval of such therapy and the second worldwide.
Addressing a High-Burden Disease
Lung cancer remains the leading cause of cancer deaths globally, with China reporting over 1 million new cases and 0.73 million deaths in 2022. While surgery and chemotherapy are standard for resectable disease, recurrence rates remain high, underscoring the need for more effective perioperative strategies.
Immunotherapy's Role
PD-1 inhibitors like Toripalimab are reshaping cancer care by reactivating immune cells to target tumors. NEOTORCH is the first global Phase 3 study of an anti-PD-1 antibody in NSCLC perioperative treatment to show positive EFS results, published in JAMA in 2024.
Outlook
The final analysis will be presented at an upcoming international academic conference. With multiple indications already approved across China and internationally, Toripalimab continues to expand its role in oncology.
1877.HK has traded between HKD 17.54 to HKD 38.64 over the past year. The stock closed Tuesday's trading at HKD 21.00, down 3.05%.
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