Corbus Pharmaceuticals Holdings, Inc. (CRBP), a clinical-stage company, Tuesday announced that it broadly aligned with the FDA on the registration path for CRB-701, a highly stable Nectin-4 targeting ADC, in head and neck squamous cell carcinoma (HNSCC) and cervical cancer.
With alignment now secured, Corbus can advance the proposed registrational study design and endpoints to support potential accelerated approval of CRB-701 in second-line HNSCC and cervical cancer.
The second-line registrational study designs for CRB-701 include 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 (ORR) as the primary endpoint and potential full approval granted on overall survival (OS) benefit for HNSCC.
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 for cervical cancer.
The company will continue interactions with the FDA to finalize the protocols and statistical analysis plans for the registrational studies.
The registrational study for CRB-701 in second-line HNSCC is expected to be initiated in mid-2026.
A phase 1/2 study of CRB-701 in both HNSCC and cervical cancer is ongoing, with updated data to be presented at the upcoming 2026 American Society of Clinical Oncology (ASCO) Annual Meeting next month.
On a separate note, the company said that its chief medical officer, Dominic Smethurst, is stepping down from his role and his last day with the biopharmaceutical firm will be on June 30, 2026.
In pre-market activity, CRBP is down 1.38% at $10.
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