NORWOOD, Mass., July 28, 2026
Corbus Pharmaceuticals Holdings, Inc. has received U.S. Food and Drug Administration (FDA) clearance to initiate TEMPO-1, the company’s registrational Phase 3 study evaluating CRB-701, a next-generation Nectin-4-targeted antibody-drug conjugate (ADC), in patients with second-line (2L) oropharyngeal squamous cell carcinoma (OPSCC). The FDA clearance marks a major regulatory milestone for Corbus as it advances the development of a novel oncology therapy for a patient population with significant unmet medical needs. TEMPO-1 is expected to begin patient enrollment in September 2026 and is designed to evaluate whether CRB-701 can improve clinical outcomes compared with currently available therapies. Supported by encouraging Phase 1/2 clinical data presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, the registrational study could pave the way toward accelerated FDA approval for one of the fastest-growing forms of head and neck cancer, largely driven by human papillomavirus (HPV) infections.
FDA Clears Registrational TEMPO-1 Study for CRB-701
The TEMPO-1 clinical trial is a randomized, controlled registrational study expected to enroll approximately 250 patients with second-line oropharyngeal squamous cell carcinoma. The trial will compare CRB-701 against physician-selected standard treatments, including capecitabine, cetuximab, or docetaxel. The study’s primary endpoint is objective response rate (ORR), which is intended to support a potential accelerated FDA approval, while overall survival (OS) will serve as the key endpoint for potential full regulatory approval. Oropharyngeal squamous cell carcinoma represents approximately half of all head and neck cancer cases treated in the second-line setting within the United States, with an estimated 14,000 eligible patients annually. The disease continues to increase in incidence due to the growing prevalence of HPV-associated cancers, highlighting the urgent need for more effective treatment options for patients whose disease progresses after first-line therapy.
Phase 1/2 Data Demonstrates Promising Antitumor Activity
The FDA’s decision to allow the registrational study was supported by encouraging results from Corbus’ ongoing Phase 1/2 clinical trial, which were presented during the 2026 ASCO Annual Meeting. Among patients with second-line or later OPSCC treated with the 3.6 mg/kg dose of CRB-701, investigators reported 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, with follow-up continuing. CRB-701 is a next-generation antibody-drug conjugate that targets Nectin-4, a clinically validated tumor-associated antigen highly expressed in head and neck cancers, cervical cancer, and several additional solid tumors. The investigational therapy utilizes a site-specific cleavable linker and the MMAE payload to selectively deliver cytotoxic treatment directly to cancer cells while minimizing exposure to healthy tissue. The program has already received FDA Fast Track Designations for both head and neck squamous cell carcinoma and cervical cancer, further supporting its accelerated clinical development.
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Advancing Targeted Therapy for HPV-Associated Head and Neck Cancer
The launch of TEMPO-1 represents an important step toward expanding treatment options for patients with HPV-driven oropharyngeal cancer, an area where therapeutic advances remain limited despite rising disease incidence. Current second-line therapies often produce modest clinical benefit, underscoring the importance of developing more effective targeted oncology treatments. By leveraging Nectin-4-targeted ADC technology, Corbus aims to deliver a precision medicine approach capable of improving response rates while supporting a favorable safety profile. With patient enrollment expected to begin in September 2026, the registrational study will play a critical role in determining whether CRB-701 can become a new treatment option for patients with recurrent or metastatic OPSCC. The FDA clearance further strengthens Corbus Pharmaceuticals’ oncology pipeline and reinforces the growing role of antibody-drug conjugates in the future of precision cancer therapy.
Source: Corbus Pharmaceuticals press release
