Corbus reports FDA alignment for CRB-701, CMO Dominic Smethurst departure

Corbus Pharmaceuticals (CRBP) announced broad alignment with the FDA on the registration path for CRB-701, the company’s next-generation, highly stable Nectin-4 targeting ADC, in head and neck squamous cell carcinoma and cervical cancer. Corbus also announced that Dominic Smethurst is stepping down from his role as chief medical officer; his last day with the company will be June 30. The agreed upon second-line registrational study designs for CRB-701 include: HNSCC: a single, randomized controlled study exploring the efficacy and safety of CRB-701 compared to physicians’ choice chemotherapy with potential accelerated approval using objective response rate as the primary endpoint and potential full approval granted on overall survival benefit. Cervical cancer: a single, randomized controlled study exploring the efficacy and safety of CRB-701 compared to physicians’ choice of chemotherapy or Tivdak with potential accelerated approval using ORR as the primary endpoint and potential full approval granted on OS benefit. Continued interactions with the FDA planned to finalize the protocols and statistical analysis plans for the registrational studies.