Corbus obtained broad FDA agreement on the registration path for its next-generation ADC CRB-701 in second-line HNSCC and cervical cancer. The FDA endorsed single randomized controlled trials comparing CRB-701 against physicians’ choice chemotherapy or Tivdak®, using objective response rate as the primary endpoint for accelerated approval and overall survival for full approval.

Updated Phase 1/2 monotherapy data for CRB-701 will be presented at the American Society of Clinical Oncology Annual Meeting in Chicago on May 29–June 2, 2026. The data package will include response durability analyses and subgroup outcomes for HNSCC patients, building on prior dose optimization findings from ESMO 2025.

Dr. Dominic Smethurst, Corbus’ Chief Medical Officer, will step down on June 30, 2026, after guiding early development of CRB-701 through clinical proof-of-concept. The company plans to appoint new senior leaders to support late-stage development and regulatory submission efforts.

Corbus expects to initiate the registrational study in second-line HNSCC by mid-2026 and to report combination data of CRB-701 with Keytruda® in first-line HNSCC patients in Q4 2026. Ongoing interactions with the FDA will finalize study protocols and statistical analysis plans ahead of patient enrollment.