NMPA (China) accepts a new drug application for toripalimab + etoposide to treat extensive stage small cell lung cancer
The board of directors of Shanghai Junishi Biosciences is pleased to announce that the company has received the Acceptance Notice issued by the National Medical Products Administration
The supplemental new drug application for toripalimab (trade name: Tuoyi, product code: JS001) in combination with etoposide in plus platinum as the first-line treatment of extensive-stage small cell lung cancer (“ES-SCLC”) has been accepted. Review conclusion: Following the review, the application is accepted pursuant to Article 32 of the Administrative License Law of the People’s Republic of China.
The supplemental new drug application is mainly based on the EXTENTORCH study (NCT04012606), which is a randomized, double-blind, placebo-controlled, multi-center Phase III clinical study, aiming to compare the efficacy and safety of toripalimab or placebo in combination with etoposide plus platinum for the first-line treatment of ES-SCLC. This study is led by Professor Cheng Ying vice president of Chinese Society of Clinical Oncology (CSCO), from Jilin Cancer Hospital, as the principal investigator. The study was launched in 51 centers nationwide, where patients were randomly allocated in the ratio of 1:1 to receive treatment of toripalimab or placebo in combination with etoposide plus platinum for 4-6 cycles, and then continued to receive maintenance treatment with toripalimab or placebo until disease progression, intolerable toxicity or other conditions requiring termination of treatment as specified in the protocol.
In May 2023, the primary endpoints of the EXTENTORCH study met the pre-defined efficacy boundary, and toripalimab thus became the first PD-1 inhibitor in the world which had met the primary endpoints of both overall survival (“OS”) and progression-free survival (“PFS”) in the Phase III study for the first-line treatment of ES-SCLC. The results showed that, compared to chemotherapy alone, toripalimab in combination with chemotherapy for the first-line treatment of ES-SCLC could significantly prolong the PFS and OS of patients. The safety profile of toripalimab was similar with previous studies, and no new safety signals were identified. Detailed data will be presented at upcoming international academic conference.
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