Corbus Doses First Patient in Key OPSCC Trial for CRB-701

Event summary

First patient dosed in TEMPO-1 trial for CRB-701 in 2L+ OPSCC patients.
TEMPO-1 is a randomized controlled study (n=250) comparing CRB-701 to standard treatments.
CRB-701 achieved a 42.9% ORR in Phase 1/2 data presented at ASCO 2026.
FDA granted two Fast Track designations to CRB-701 for HNSCC and cervical cancer.

The big picture

Corbus' TEMPO-1 trial marks a critical step in addressing the rising incidence of HPV-driven OPSCC, a disease affecting ~14,000 patients annually in the U.S. The study's design, targeting a 42.9% ORR observed in earlier trials, positions CRB-701 as a potential disruptor in a treatment landscape stagnant since the introduction of PD-1 inhibitors. Success could expand Corbus' footprint in oncology, complementing its obesity pipeline.

What we're watching

Clinical Efficacy: Whether CRB-701 can replicate Phase 1/2 ORR results in the larger TEMPO-1 trial.
Regulatory Pathway: The pace at which FDA may grant accelerated approval based on ORR data.
Market Opportunity: How CRB-701 positions against existing treatments for 2L+ OPSCC patients.