Clinical TrialMay 26, 2026, 07:02 AM
Corbus CRB-701 Shows 42.9% ORR in OPSCC; Registrational Study Soon
AI Summary
Corbus Pharmaceuticals reported updated positive Phase 1/2 clinical data for CRB-701, a Nectin-4 targeted ADC, in second-line oropharyngeal squamous cell carcinoma (OPSCC) and cervical cancer. The data showed robust activity and a favorable safety profile, affirming the company's strategy. Based on these results, Corbus is on track to initiate a registrational study for CRB-701 in 2L OPSCC in summer 2026, with broad FDA alignment on the trial design. Similar FDA alignment was reached for a 2L cervical cancer study.
Key Highlights
- CRB-701 showed 42.9% confirmed ORR in 2L OPSCC at 3.6 mg/kg, with median DOR of 6.3 months.
- CRB-701 showed 34.4% confirmed ORR in 2L cervical cancer at 3.6 mg/kg, with median DOR of 8.0 months.
- CRB-701 was generally safe and well tolerated, with treatment discontinuation rates below 3%.
- Registrational study (TEMPO-1) for 2L OPSCC is on track to initiate in summer 2026.
- Broad FDA alignment was reached for trial designs in both 2L OPSCC and 2L cervical cancer.
- CRB-701 has two FDA Fast Track designations in HNSCC and cervical cancer.