Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced encouraging results from the Phase III EXTENTORCH study, which assessed the company’s programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) in combination with chemotherapy for first-line extensive stage small cell lung cancer (ES-SCLC). The trial has successfully reached its pre-set primary endpoint, signaling that a market filing is anticipated in the near term.
Design and Findings of the Phase III Study
The randomized, double-blind, placebo-controlled, multi-center Phase III study was designed to evaluate the safety and efficacy of the combined treatment regimen. The findings indicate that, compared to chemotherapy alone, the combination of Tuoyi with chemotherapy can significantly extend progression-free survival (PFS) and overall survival (OS). The safety profile of the combination regimen is consistent with previous studies, with no new safety signals identified. Detailed results will be presented at upcoming international conferences.
ES-SCLC: A Challenging Subtype of Lung Cancer
ES-SCLC is a particularly challenging subtype of lung cancer with a poor prognosis, accounting for approximately 15% of all lung cancer cases. The majority of cases (over 70%) are already at an advanced stage (IV or extensive stage) at the time of diagnosis. In China, four PD-L1 inhibitors have been approved for the treatment of ES-SCLC, including AstraZeneca’s Imfinzi (durvalumab), Roche’s Tecentriq (atezolizumab), Henlius’s serplulimab, and Hengrui Medicine’s Airuili (adebrelimab). Additionally, Akeso Bio’s ivonescimab is in development for ES-SCLC, with Phase Ib results already published.-Fineline Info & Tech
