Corbus Pharmaceuticals Holdings Inc. (NASDAQ:CRBP) said it has aligned with the U.S. Food and Drug Administration on the regulatory pathway for CRB-701, its Nectin-4–targeting antibody-drug conjugate being developed to treat head and neck squamous cell carcinoma (HNSCC) and cervical cancer.
The company said the FDA agreed on registrational study designs involving one randomized controlled trial for each indication, comparing CRB-701 against physician-selected chemotherapy. In both trials, objective response rate will serve as the primary endpoint for potential accelerated approval, while overall survival data could support full approval.
For the cervical cancer trial, the comparator group will include physician’s choice chemotherapy or Tivdak. Corbus said it plans to continue discussions with the FDA to finalize study protocols and statistical analysis plans for the registration studies.
Corbus expects to begin a registrational trial of CRB-701 in second-line treatment of head and neck squamous cell carcinoma in mid-2026. The company also plans to present updated clinical results from its Phase 1/2 study of CRB-701 at the American Society of Clinical Oncology Annual Meeting scheduled for May 29 through June 2, 2026, in Chicago.
In addition, Corbus said it expects to report data in the fourth quarter of 2026 from a study evaluating CRB-701 combined with Keytruda in first-line patients with head and neck squamous cell carcinoma.
Separately, the company announced that Chief Medical Officer Dr. Dominic Smethurst will step down from his position, with his final day scheduled for June 30, 2026.
“We expect to initiate a registrational study for CRB-701 in second-line HNSCC in mid-2026,” said Yuval Cohen, Chief Executive Officer of Corbus.