Junshi Biosciences Announces Acceptance of the Supplemental New Drug Application for Toripalimab as the First-line Treatment of Extensive-stage Small Cell Lung Cancer

SHANGHAI, China, July 19, 2023 (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 supplemental new drug application for toripalimab, the company’s anti-PD-1 monoclonal antibody, in combination with etoposide plus platinum for the first-line treatment of patients with extensive-stage small cell lung cancer (“ES-SCLC”), has been accepted for review by the National Medical Products Administration (“NMPA”).

According to data released by GLOBOCAN 2020, lung cancer is currently the most prevalent malignant tumor with the highest mortality rate in China. Small cell lung cancer (“SCLC”) is the most aggressive subtype of lung cancer, accounting for approximately 15%-20% of all lung cancer cases with characteristics including rapid progression, early metastasis and a poor prognosis. SCLC is divided into limited-stage small cell lung cancer (“LS-SCLC”) and ES-SCLC. For patients with LS-SCLC, standard chemotherapy and radiotherapy can achieve an objective response rate of approximately 90% and a five-year survival rate of approximately 25%. However, most patients are diagnosed with ES-SCLC by the time they seek medical treatment, with a median survival time of less than one year and a two-year survival rate below 10%. SCLC, and particularly ES-SCLC, pose a significant and unresolved medical challenge.

The supplemental new drug application is mainly based on EXTENTORCH (NCT04012606), a randomized, double-blind, placebo-controlled, multi-center Phase 3 clinical study. EXTENTORCH aims to compare the efficacy and safety of toripalimab or placebo in combination with etoposide plus platinum for the first-line treatment of ES-SCLC. The principal investigator for this study is Professor Ying CHENG, who is from Jilin Cancer Hospital and serves as the vice president of the Chinese Society of Clinical Oncology (CSCO).

EXTENTORCH was launched in 51 centers nationwide, where patients were randomized in a 1:1 ratio to receive either toripalimab or placebo in combination with etoposide plus platinum. The treatment would be administered for 4-6 cycles, after which patients would receive maintenance treatment with toripalimab or placebo until disease progression, intolerable toxicity or other circumstances requiring termination of treatment as specified in the protocol.