Genmab A/S said its experimental antibody combination met both primary endpoints in a Phase 3 trial, with lower death hazard and higher tumor-response odds among patients with PD-L1-positive advanced head and neck cancer.
At LiGeR-HN1’s first interim analysis, the death hazard in the combination arm was half that in the pembrolizumab-only group (hazard ratio, 0.50; 95% CI, 0.37 to 0.67; p<0.0001), Genmab said Oct. 28. An independent data monitoring committee assessed the analysis.
The combination also had an objective-response odds ratio of 3.17 versus pembrolizumab alone (95% CI, 2.06 to 4.89; p<0.0001). Genmab said the results were seen regardless of HPV status.
LiGeR-HN1 evaluated first-line treatment for PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma. Petosemtamab is an investigational bispecific antibody. Genmab cited Everett E. Vokes, MD, who described the result as the first positive Phase 3 study in this patient population in several years.
Genmab said the combination was generally well tolerated, with no new safety signals and a profile consistent with prior experience using each drug. Genmab said it plans to discuss the findings with regulators worldwide and submit the complete dataset for a future medical meeting.
