Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP) announced it has reached agreement with the U.S. Food and Drug Administration on the registration path for CRB-701, its Nectin-4 targeting antibody-drug conjugate, in head and neck squamous cell carcinoma and cervical cancer.

The agreed upon second-line registrational study designs include a single, randomized controlled study for each indication comparing CRB-701 to physicians' choice chemotherapy. Both studies would use objective response rate as the primary endpoint for potential accelerated approval, with potential full approval based on overall survival benefit.

For cervical cancer, the comparator arm would include physicians' choice of chemotherapy or Tivdak. The company plans continued interactions with the FDA to finalize protocols and statistical analysis plans for the registrational studies.

Corbus expects to initiate a registrational study for CRB-701 in second-line head and neck squamous cell carcinoma in mid-2026. The company will present updated clinical data from its Phase 1/2 study of CRB-701 at the 2026 American Society of Clinical Oncology Annual Meeting, scheduled for May 29 through June 2 in Chicago.

The company also anticipates reporting data with CRB-701 in combination with Keytruda in first-line head and neck squamous cell carcinoma patients in the fourth quarter of 2026.

Separately, Corbus announced that Dr. Dominic Smethurst will step down from his role as Chief Medical Officer, with his last 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.