Corbus Pharmaceuticals Aligns with FDA on CRB-701 Registrational Path; CMO to Resign

On April 7, 2026, Corbus Pharmaceuticals announced broad alignment with the FDA regarding the registration path for CRB-701, a next-generation Nectin-4 targeting antibody drug conjugate (ADC). The agreement covers registrational study designs for second-line head and neck squamous cell carcinoma (HNSCC) and cervical cancer. Both indications will utilize single, randomized controlled studies with objective response rate (ORR) as the primary endpoint to support potential accelerated approval, followed by overall survival (OS) for full approval. The company expects to initiate the registrational study for HNSCC in mid-2026. In addition to regulatory updates, Corbus announced that Dr. Dominic Smethurst will resign as Chief Medical Officer, effective June 30, 2026. Updated monotherapy data for CRB-701 in HNSCC and cervical cancer from Phase 1/2 trials have been accepted for presentation at the ASCO 2026 Annual Meeting. Furthermore, the company anticipates reporting data for CRB-701 in combination with Keytruda for first-line HNSCC in Q4 2026.