Shanghai Junshi Biosciences Co., Ltd. (1877) announced that a multi-center, open-label, randomized controlled phase III clinical study (NCT06505837) comparing JS001sc (toripalimab injection, subcutaneous) with toripalimab injection (TUOYI®) in combination with chemotherapy for first-line treatment of recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC) has met its primary endpoints. According to the announcement, the company plans to submit a new drug application for the subcutaneous formulation in the near future.
JS001sc is noted as the first domestic anti-PD-1 monoclonal antibody subcutaneous formulation to enter phase III clinical trials, aiming to offer more convenient administration for patients. The trial, led by the principal investigator from Hunan Cancer Hospital, assessed drug exposure, efficacy, and safety for patients with recurrent or metastatic non-squamous NSCLC. Results indicated non-inferior drug exposure compared to toripalimab injection, with comparable efficacy and safety profiles. Detailed data will be presented at an upcoming international academic conference.
According to GLOBOCAN 2022, lung cancer remains a leading cause of both new cancer cases and cancer-related deaths in China, with NSCLC accounting for approximately 85% of all lung cancer cases. The announcement highlights the growing role of immunotherapy in treating a wide range of tumors but emphasizes the need for more patient-friendly options, given the challenges posed by lengthy intravenous infusions. The company further notes that it will continue to communicate with regulatory authorities regarding the new drug application, while also emphasizing the inherent risks and uncertainties in drug research and commercialization.
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