Corbus Doses First Patient in TEMPO-1 Registrational Study of Nectin-4 ADC CRB-701 in 2L+ Oropharyngeal Cancer
核心洞察
Corbus Pharmaceuticals has dosed the first patient in TEMPO-1, a randomized registrational study of the Nectin-4 (搜索) targeted antibody drug conjugate CRB-701 in second-line or later oropharyngeal squamous cell carcinoma (搜索).
TEMPO-1 will enroll 250 patients and compare CRB-701 with investigator's choice of capecitabine, cetuximab or docetaxel, with objective response rate as the primary endpoint.
In Phase 1/2 data presented at ASCO 2026, CRB-701 given at 3.6 mg/kg produced a confirmed objective response rate of 42.9% in 2L+ OPSCC patients.
Corbus Pharmaceuticals Holdings has dosed the first patient in TEMPO-1, a randomized registrational study of CRB-701, a next-generation Nectin-4 (搜索) targeted antibody drug conjugate (ADC), in patients with second-line and beyond (2L+) oropharyngeal squamous cell carcinoma (搜索) (OPSCC). The company announced the milestone on Sept. 29, 2026.
TEMPO-1 is designed to generate the evidence needed to support a potential regulatory submission, according to Leonardo Nicacio, M.D., Chief Medical Officer of Corbus Pharmaceuticals. "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," Nicacio said. "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."
Study Design and Endpoints
TEMPO-1 is a randomized controlled study enrolling 250 patients. It is designed to evaluate the efficacy and safety of CRB-701 compared with investigator's choice of capecitabine, cetuximab or docetaxel. The 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 FDA's clearance for TEMPO-1 to proceed was supported by results from Corbus' ongoing Phase 1/2 clinical study of CRB-701, which were 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, which is ongoing.
Unmet Need in Recurrent or Metastatic Disease
The study addresses a population with limited options after frontline therapy. "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, Florida, 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 United States. The disease primarily affects men in their 50s and 60s who have little or no history of smoking or heavy alcohol use. 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. Approximately 7,000 patients are estimated to die from the disease in the U.S. each year.
CRB-701 Construct and Regulatory Status
CRB-701 (SYS6002) is a next-generation ADC targeting Nectin-4 (搜索). It contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using monomethyl auristatin E (搜索) (MMAE) as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer and is highly expressed in other tumor types such as cervical cancer (搜索) and head and neck squamous cell carcinoma (搜索) (HNSCC). The FDA has granted two Fast Track designations to CRB-701, in HNSCC and cervical cancer.
Corbus Pharmaceuticals Holdings is a clinical-stage company focused on new therapies in oncology and obesity. Its pipeline includes CRB-701 for the treatment of Nectin-4 (搜索)-expressing tumors and CRB-913, an orally delivered, highly peripherally restricted CB1 inverse agonist for the treatment of obesity. The company is headquartered in Norwood, Massachusetts.
Corbus noted in its disclosure that 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.