On July 28, 2026 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company") a clinical-stage company focusing on developing new therapies in oncology and obesity, reported that the U.S. Food and Drug Administration (FDA) has cleared the start of the Company’s registrational study ("TEMPO-1") of CRB-701, a next-generation Nectin-4 targeted antibody drug conjugate (ADC), in second-line (2L) oropharyngeal squamous cell carcinoma (OPSCC).
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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.
The incidence and prevalence of OPSCC continue to rise in the U.S. largely driven by HPV infection. 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 succumb to the disease in the United States alone.
The FDA’s decision to allow the registrational 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) (Free ASCO Whitepaper) 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).
"The data presented at ASCO (Free ASCO Whitepaper) provided important insight into the potential clinical path for CRB-701 in 2L oropharyngeal cancer, a distinct tumor-type that is on the rise due to HPV infections," said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. "Unfortunately, current treatment options have shown limited efficacy underscoring the need for additional therapeutic options. OPSCC represents a significant commercial opportunity."
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.
(Press release, Corbus Pharmaceuticals, JUL 28, 2026, View Source [SID1234669456])