Corbus Pharmaceuticals Holdings, Inc. Reaches FDA Alignment On Registration Pathway For CRB-701 In Head And Neck And Cervical Cancers

Corbus Pharmaceuticals Holdings, Inc., a clinical-stage company developing new therapies in oncology and obesity, announced that it has reached broad alignment with the U.S. Food and Drug Administration on the registration pathway for CRB-701. CRB-701 is Corbus’ next-generation, highly stable antibody-drug conjugate (ADC) designed to target Nectin-4, and the planned development program focuses on patients with head and neck squamous cell carcinoma (HNSCC) and cervical cancer. The company also reported that Dominic Smethurst will step down from his position as Chief Medical Officer, with his final day set for June 30, 2026.

Corbus outlined the key elements of the agreed-upon second-line registrational study designs. For HNSCC, the company will conduct a single randomized controlled trial comparing CRB-701 to physicians’ choice of chemotherapy. This study may be eligible for accelerated approval based on objective response rate, with full approval tied to demonstrated overall survival benefit. 

For cervical cancer, the registrational study will also be a single randomized controlled trial, comparing CRB-701 with either physicians’ choice chemotherapy or Tivdak, using the same approval framework of accelerated approval on response rate and potential full approval based on survival outcomes. Corbus plans to continue working closely with the FDA to finalize study protocols and statistical analysis plans.

The company will share updated clinical results from the ongoing Phase 1/2 trial of CRB-701 at the 2026 American Society of Clinical Oncology Annual Meeting in Chicago. The presentation will include findings on clinical response durability and subgroup analyses in HNSCC patients. 

Corbus has previously presented dose optimization data from this program—including promising efficacy and safety signals—at the 2025 European Society for Medical Oncology Congress. Additionally, the company expects to report data in the fourth quarter of 2026 from a study evaluating CRB-701 in combination with Keytruda in first-line HNSCC patients, which may support further registration-enabling development.

Yuval Cohen, Ph.D., Chief Executive Officer of Corbus, stated that the regulatory progress represents an important step as the company advances CRB-701 toward late-stage development. He noted that Corbus looks forward to sharing new monotherapy results at ASCO and anticipates beginning the registrational trial for second-line HNSCC in mid-2026. 

Yuval Cohen emphasized that this milestone moves CRB-701 from early proof of concept toward potential future regulatory submission. He added that Corbus will be expanding its leadership team to support this next phase and expressed appreciation for Dr. Smethurst’s work in advancing the company’s pipeline through early-stage development.