Corbus’ CRB-701 Achieves 42.9% ORR in 2L OPSCC and 34.4% in Cervical Cancer
CRBP•CRB-701 Phase 1/2 data in 2L OPSCC at 3.6 mg/kg showed 42.9% ORR, median DOR 6.3 months and PFS 5.6 months; 2L cervical cancer reported 34.4% ORR with median DOR 8.0 months. Safety discontinuations remained under 3% and the TEMPO-1 registrational trial begins summer 2026.
1. Phase 1/2 Trial Design and Safety
The ongoing multicenter Phase 1/2 study enrolled 317 patients across the U.S. and Europe, with efficacy evaluable cohorts of 71 OPSCC and 70 cervical cancer patients treated at 2.7 mg/kg and 3.6 mg/kg. CRB-701 was generally well tolerated, with Grade 3 adverse events in 19.2%, Grade 4 in 0.9%, ocular AEs in 66.2%, and overall discontinuations below 3%.
2. Efficacy in OPSCC
In second-line oropharyngeal squamous cell carcinoma at 3.6 mg/kg, CRB-701 achieved a confirmed objective response rate of 42.9%, median duration of response of 6.3 months and median PFS of 5.6 months. HPV-positive tumors comprised 85.4% of oropharyngeal cases, with 8 of 9 partial responses occurring in this subgroup.
3. Efficacy in Cervical Cancer
Cervical cancer patients dosed at 3.6 mg/kg showed a confirmed ORR of 34.4%, including two complete responses, with a median duration of response of 8.0 months and median PFS of 4.3 months. The disease control rate reached 75%, underscoring sustained benefit in this HPV-driven population.
4. Registrational Trial Planning
Building on these results, Corbus plans to initiate the TEMPO-1 registrational trial in second-line OPSCC in summer 2026. A company conference call on May 26 and a scientific event on June 1 will review the data and outline the path forward.
