Genmab A/S Announces Data From Its Phase 3 LiGeR-HN1 Study Of Petosemtamab Demonstrates 50% Death Risk Reduction For Treatment Of Head And Neck Squamous Cell Carcinoma

Genmab A/S (NASDAQ:GMAB) today announced positive topline results from the global Phase 3 LiGeR-HN1 trial (NCT06525220) evaluating petosemtamab, an investigational IgG1-bispecific antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5), in combination with pembrolizumab versus pembrolizumab in patients with first-line (1L) PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). Based on the first interim analysis assessed by an independent data monitoring committee (IDMC), treatment with the petosemtamab combination demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), reducing the risk of death by 50%, and objective response rate (ORR) versus pembrolizumab [OS: HR 0.50 (95% CI, 0.37, 0.67); p<0.0001; ORR: odds ratio 3.17 (95% CI, 2.06, 4.89; p<0.0001), meeting its dual primary endpoints, regardless of HPV status.

The safety profile of petosemtamab when administered in combination with pembrolizumab was generally well tolerated and consistent with the previously reported safety profiles of the individual agents (petosemtamab and pembrolizumab). No new safety signals were identified.