Primary Endpoints Met in Final Analysis of Ph 3 Study for Perioperative Toripalimab plus Chemotherapy for Resectable Stage II-III NSCLC
Shanghai Junshi Biosciences announced that a randomized, double-blind, placebo-controlled, multi-center phase III clinical study (“NEOTORCH”, NCT04158440) of the company’s product toripalimab in combination with platinum-containing doublet chemotherapy as perioperative treatment for resectable stage II-III non-small cell lung cancer (“NSCLC”) patients has finished its final analysis. The primary endpoints of event-free survival (“EFS”) and major pathological response (“MPR”) rate in the stage II-III population, as well as the MPR rate in the stage III population, met the pre-defined efficacy boundary. Junshi Biosciences now plans to submit a supplemental new drug application (“sNDA”) for the product to regulatory authorities in the near future. Toripalimab combined with chemotherapy has already been approved for perioperative treatment of patients with resectable stage III NSCLC, and this new sNDA will aim to expand the approval to perioperative treatment of resectable stage II-III NSCLC.
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