Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) announced that the U.S. Food and Drug Administration has cleared the start of its registrational study, known as TEMPO-1, of CRB-701 in second-line oropharyngeal squamous cell carcinoma (OPSCC). The company expects to begin enrollment in September 2026.

TEMPO-1 is a randomized controlled study enrolling 250 patients, designed to evaluate the efficacy and safety of CRB-701 compared with investigator's choice of capecitabine, cetuximab, or docetaxel. The study's primary endpoint is objective response rate, intended to support a potential accelerated approval, while overall survival is intended to support potential conversion to full approval.

The FDA's clearance was supported by data from Corbus' ongoing Phase 1/2 clinical study of CRB-701, presented at the 2026 American Society of Clinical Oncology Annual Meeting. In patients with second-line or later OPSCC treated at the 3.6 mg/kg dose, CRB-701 achieved a confirmed objective response rate of 42.9%, a median duration of response of 6.3 months, and a median progression-free survival of 5.6 months.

OPSCC is estimated to represent one in two head and neck cancer patients in the second-line setting in the U.S., with approximately 14,000 patients eligible annually for treatment. The disease is largely driven by HPV infection and primarily affects men in their 50s and 60s. Approximately 7,000 patients are estimated to die from the disease each year in the United States.

CRB-701 is a Nectin-4 targeted antibody drug conjugate. The FDA has granted two Fast Track designations to CRB-701, in head and neck squamous cell carcinoma and cervical cancer.