Phase 3 CRB-701 nectin-4–targeted ADC (MMAE tubulin inhibitor) vs chemo/EGFR options in R/M OPSCC

Corbus Pharmaceuticals’ TEMPO-1 is a randomized, open-label, 2-arm Phase 3 trial testing CRB-701 (also referenced as SYS6002), a nectin-4–directed monoclonal antibody–drug conjugate that delivers the microtubule toxin MMAE, versus investigator’s choice single-agent therapy: capecitabine (oral prodrug of 5-FU that inhibits thymidylate synthase), cetuximab (EGFR-directed monoclonal antibody; originally from ImClone/Bristol Myers Squibb and now marketed by Lilly and Merck KGaA/EMD Serono in different regions), or docetaxel (taxane microtubule inhibitor). The study enrolls recurrent/metastatic oropharyngeal squamous cell carcinoma after platinum chemotherapy and a PD-(L)1 inhibitor, measuring objective response rate by CT/MRI and safety, with quality-of-life assessments. Commercially, it’s a registrational bet that a nectin-4 ADC can outperform common post–platinum/IO single-agent options in an area where outcomes are modest; today’s care after progression on platinum + PD-(L)1 is sequential single-agent therapy (taxanes, cetuximab, antimetabolites) and clinical trials, with limited durable responses.