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.
Share:
More News
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.
“Many solid tumors remain difficult to treat despite advances in immunotherapy,” said Rustam Esanov, CEO and co-founder of Reprogram Biosciences. “Our approach is differentiated by its reprogramming of the tumor itself into a site of immune activation, rather than relying on exogenous immune cells or broadly acting systemic agents.”
Mabwell, an innovation-driven biopharmaceutical company with a fully integrated industry chain, today announced that the first patient has been dosed in a Phase III clinical trial evaluating its novel Nectin-4-targeting ADC (Bulumtatug Fuvedotin, or BFv, R&D code: 9MW2821) for the treatment of locally advanced or metastatic triple-negative breast cancer (TNBC).