Corbus Pharmaceuticals Announces First Patient Dosed in TEMPO-1 Registrational Study of CRB-701 in Patients with 2L+ Oropharyngeal Cancer
Key Highlights
- ➤TEMPO-1 first patient dosed in registrational 2L+ OPSCC study of CRB-701 (CRBP)
- ➤TEMPO-1 randomized study plans 250 patients versus capecitabine, cetuximab or docetaxel
- ➤CRB-701 Phase 1/2 confirmed ORR 42.9% at 3.6 mg/kg in 2L+ OPSCC
- ➤CRB-701 Phase 1/2 median duration of response 6.3 months at 3.6 mg/kg
- ➤CRB-701 Phase 1/2 median progression-free survival 5.6 months at 3.6 mg/kg
Expert Statements
Cesar A. Perez, Director of the Drug Development Unit at Sarah Cannon Research Institute at Florida Cancer Specialists & Research Institute; Principal Investigator of the TEMPO-1 study
“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.”
Cesar A. Perez, Director of the Drug Development Unit at Sarah Cannon Research Institute at Florida Cancer Specialists & Research Institute; 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.”
Cesar A. Perez, Director of the Drug Development Unit at Sarah Cannon Research Institute at Florida Cancer Specialists & Research Institute; Principal Investigator of the TEMPO-1 study
“We are proud that SCRI at Florida Cancer Specialists & Research Institute is helping evaluate a potential new therapeutic approach through the TEMPO-1 study.”
Leonardo Nicacio, 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.”
Leonardo Nicacio, 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.”
Leonardo Nicacio, Chief Medical Officer of Corbus Pharmaceuticals
“We are excited to be underway with TEMPO-1, which is designed to generate the evidence needed to support a potential regulatory submission.”
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
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