Hold Lifted on Lung/Breast Cancer ADC Drug

FDA has lifted a partial clinical hold on a MediLink Therapeutics and BioNTech Phase 1 trial evaluating BNT326/YL202 (NCT05653752), a HER3-targeted antibody-drug conjugate for treating EGFR-mutated non–small cell lung cancer and hormone receptor–positive, HER2-negative breast cancer. The hold was in response to study sponsor MediLink observing a dose-dependent trend of treatment-related adverse events (i.e., neutrophil count decrease and increasing rate of mucositis events).

The companies recently submitted an updated data analysis, updated investigator brochure and informed consent for patients, and an amended clinical trial protocol to meet FDA’s requirements to incorporate additional risk mitigation measures, a press release says. “The trial recruitment will be re-initiated,” they say, adding that clinical development will focus on dose levels no higher than 3 mg/kg, “where the safety profile was manageable and encouraging clinical activity was observed.”