China’s NMPA Grants Breakthrough Therapy Designation to OncoC4’s Gotistobart for Squamous Non-Small Cell Lung Cancer
OncoC4, a late-stage biopharmaceutical company, announced that China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to gotistobart (BNT316/ONC-392), a next-generation anti-CTLA-4 antibody, for the treatment of squamous non-small cell lung cancer (sqNSCLC) in patients who have progressed on prior immuno-oncology therapies. Developed in collaboration with BioNTech, gotistobart aims to address the urgent need for effective treatments for this aggressive lung cancer subtype, which accounts for 25-30% of all non-small cell lung cancer cases and has a five-year survival rate of just 15%. The BTD, which expedites development and regulatory review for therapies targeting serious conditions, was based on promising safety and efficacy data from the first stage of the ongoing Phase 3 PRESERVE-003 trial. This global, two-stage, randomized trial compares gotistobart as a monotherapy against standard-of-care chemotherapy (docetaxel) in patients with metastatic sqNSCLC who have progressed…


