Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted its filing for an additional indication of Tuoyi (toripalimab). The drug is proposed to be used in combination with etoposide and platinum for the treatment of extensive stage small cell lung cancer (ES-SCLC), marking what would be the 10th indication for the programmed death-1 (PD-1) inhibitor in China.
Phase III EXTENTORCH Study Results Support NMPA Filing
The filing is supported by the EXTENTORCH study (NCT04012606), a Phase III, randomized, double-blinded, placebo-controlled, multi-center trial that evaluated the efficacy and safety of Tuoyi in combination with chemotherapy as a first-line treatment for ES-SCLC. The study successfully met its pre-set superiority boundary for the primary endpoint, demonstrating that the combination therapy significantly improved overall survival (OS) and progression-free survival (PFS) compared to chemotherapy alone. The safety profile of the combination was consistent with previous studies, with no new safety signals identified. This achievement positions Tuoyi as the world’s first PD-1 inhibitor to achieve dual primary endpoints of OS and PFS in a Phase III study for first-line ES-SCLC.
Implications for ES-SCLC Treatment and Junshi Biosciences’ Portfolio
The acceptance of the filing by the NMPA for review is a significant step for Shanghai Junshi Biosciences as it seeks to expand the application of Tuoyi in the treatment of ES-SCLC. If approved, this would be the 10th indication for the PD-1 inhibitor in China, further solidifying the company’s presence in the oncology market. The positive results from the EXTENTORCH study not only support the potential benefits of Tuoyi in ES-SCLC but also highlight the drug’s safety profile, which is crucial for its adoption in clinical practice.-Fineline Info & Tech
