Petosemtamab Combo Cuts Death Risk 50% in Phase 3 Head and Neck Cancer Trial
GMAB sits 91% above its 52-week low of $23.62 on light trading volume (0.1× avg).
Summary
Genmab's petosemtamab plus pembrolizumab hit both primary endpoints at the first interim analysis of the Phase 3 LiGeR-HN1 trial in first-line PD-L1+ recurrent/metastatic head and neck cancer. The combination cut the risk of death by 50% (OS HR 0.50, p<0.0001) and tripled the odds of response versus pembrolizumab alone (ORR odds ratio 3.17, p<0.0001), with benefit regardless of HPV status and no new safety signals. This is the first positive Phase 3 in this population in several years and follows the October 26 ESMO update showing 28.2-month median OS in Phase 2 — the Phase 3 now confirms that signal on a registrational scale. Petosemtamab already holds FDA Breakthrough Therapy Designation in this setting, and Genmab says it will engage global regulators and present the full dataset at a future medical meeting. The company hosts an investor update today at 12:00 p.m. EDT.
At the time of this announcement, GMAB was trading at $45.12 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $26.6B. The 52-week trading range was $23.62 to $46.63. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: BusinessWire.