Genmab's Petosemtamab Plus Keytruda Wins Early in First-Line Head and Neck Phase 3

  • In the Phase 3 LiGeR-HN1 trial of nearly 700 PD-L1-positive head and neck cancer patients, petosemtamab (EGFR x LGR5 bispecific, acquired with Merus) plus Keytruda beat Keytruda alone on overall survival and response rate at the first interim analysis.
  • Genmab said the combination cut the risk of death by about half regardless of HPV status, but has not released median figures or safety data.
  • Genmab shares rose about 29%; Bicara, whose rival ficerafusp alfa reads out in HPV-negative patients in mid-2027, fell 48%.
💡 Points Based on public reports

An interim OS win this early pulls approval timing forward, with one analyst now eyeing 2027 instead of 2028. It also validates the Merus acquisition. Safety is the open question, since EGFR-directed drugs carry skin and infusion toxicity, so the full dataset matters. Bicara's drop looks overdone given the HPV-negative focus, but its bar just got higher.

Genmab's cancer bispecific delivers early survival win in 'exceedingly positive' Phase 3 readout ↗