Incidence and prevalence of OPSCC continue to rise in the U.S. largely driven by HPV infection
OPSCC is estimated to represent 1 in 2 head and neck cancer patients in the 2L+ setting in the U.S. with approximately 14,000 patients eligible for treatment annually
NORWOOD, Mass., Sept. 29, 2026 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), a clinical-stage company focused on new therapies in oncology and obesity, today announced that the first patient has been dosed in its TEMPO-1 registrational study of CRB-701, a next-generation Nectin-4 targeted antibody drug conjugate (ADC), in second-line and beyond (2L+) oropharyngeal squamous cell carcinoma (OPSCC).
“For patients with recurrent or metastatic head and neck cancer, there remains a significant unmet need for new treatment options after progression on frontline therapy,” said Dr. Cesar A. Perez, Director of the Drug Development Unit at Sarah Cannon Research Institute at Florida Cancer Specialists & Research Institute in Orlando, FL, and Principal Investigator of the TEMPO-1 study. “The current standard options have been largely unchanged since the introduction of PD-1 inhibitors nearly a decade ago. We are proud that SCRI at Florida Cancer Specialists & Research Institute is helping evaluate a potential new therapeutic approach through the TEMPO-1 study.”
HPV infection is driving the rise of both the incidence and prevalence of OPSCC in the U.S. The disease primarily affects men in their 50s and 60s who have little or no history of smoking or heavy alcohol use. Each year approximately 14,000 OPSCC patients are estimated to be eligible for 2L treatment, and approximately 7,000 patients are estimated to die from the disease in the U.S. alone.
“Dosing the first patient in our TEMPO-1 trial marks an important step in advancing CRB-701 as a potentially novel targeted therapeutic for those impacted by OPSCC,” said Leonardo Nicacio, M.D., Chief Medical Officer of Corbus Pharmaceuticals. “Based on the Phase 1/2 data we presented at ASCO 2026, we believe that CRB-701 has the potential to deliver meaningful clinical benefit with a manageable safety profile in this underserved patient population. We are excited to be underway with TEMPO-1, which is designed to generate the evidence needed to support a potential regulatory submission.”
Study Design
TEMPO-1 is a randomized controlled study (n=250) 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 (ORR), which is intended to support a potential accelerated approval; overall survival (OS) is intended to support potential conversion to full approval.
FDA approval for the TEMPO-1 study to proceed was supported by results from Corbus' ongoing Phase 1/2 clinical study of CRB-701, presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. In an analysis of patients with 2L+ OPSCC treated at the 3.6 mg/kg dose, CRB-701 achieved a confirmed ORR of 42.9%, with a median duration of response (DoR) of 6.3 months and a median progression-free survival (PFS) of 5.6 months (ongoing).
About CRB-701
CRB-701 (SYS6002) is a next-generation antibody drug conjugate targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using monomethyl auristatin E (MMAE) as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer and highly expressed in other tumor types such as cervical and head and neck squamous cell carcinoma (HNSCC). The FDA has granted two Fast Track designations to CRB-701 in HNSCC and cervical cancer.
About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focusing on new therapies in oncology and obesity and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus’ pipeline includes CRB-701, a next-generation antibody drug conjugate for the treatment of Nectin-4-expressing tumors, and CRB-913, an orally delivered highly peripherally restricted CB1 inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on X, LinkedIn and Facebook.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act of 1995, as amended, including those relating to the Company's trial results, product development, clinical and regulatory timelines, including timing for completion of trials and presentation of data, anticipated timing for initiation of clinical trials, anticipated regulatory interactions and outcomes, including alignment with FDA on trial design, potential accelerated approval, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities, sufficiency of cash runway and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions. There can be no assurance that TEMPO-1 will achieve its primary or secondary endpoints, that CRB-701 will receive accelerated or full approval from the FDA, or that previously reported clinical data will be replicated in larger controlled studies.
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INVESTOR CONTACTS:
Sean Moran
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Corbus Pharmaceuticals
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