REG-Genmab Announces Statistically Significant, Clinically Meaningful Improvement in Overall Survival and Objective Response with Petosemtamab Combination at First Interim Analysis in First-Line R/M Patients with PD-L1+ Head and Neck Cancer
Key Highlights
- ➤Petosemtamab combination cut death risk 50% versus pembrolizumab alone
- ➤LiGeR-HN1 met dual primary endpoints for overall survival and objective response rate
- ➤Objective response odds were 3.17 times higher with the combination
- ➤Genmab plans global regulatory discussions and future full-data presentation
- ➤Combination safety was generally well tolerated with no new safety signals
Expert Statements
Everett E. Vokes, Chair, Department of Medicine and Physician-in-Chief, University of Chicago Medicine
“Patients with recurrent or metastatic head and neck cancer face a disease that can profoundly affect both survival and some of the most essential aspects of daily life, making progress in treatment urgently needed. As the first positive Phase 3 study in this patient population in several years, LiGeR-HN1 represents a major milestone with the potential to redefine care”
Everett E. Vokes, Chair, Department of Medicine and Physician-in-Chief, University of Chicago Medicine
“Meeting its dual primary endpoints of overall survival and objective response rate at the first interim analysis underscores the potential of petosemtamab plus pembrolizumab to transform first-line treatment for patients with PD-L1-positive disease, regardless of HPV status. These results suggest this chemotherapy-free combination could reshape the treatment of this devastating disease by establishing a new therapeutic option.”
Jan van de Winkel, Chief Executive Officer of Genmab
“These topline Phase 3 results represent a defining milestone for Genmab and further strengthen our conviction in petosemtamab as a potential first-in-class treatment option for patients with this difficult-to-treat cancer.”
Jan van de Winkel, Chief Executive Officer of Genmab
“Meaningful innovation is measured not only by scientific discovery, but by its potential to improve outcomes for patients. The LiGeR-HN1 topline findings mark an important step toward potentially bringing petosemtamab to patients with recurrent or metastatic head and neck cancer, and we look forward to engaging with regulatory authorities globally and sharing the full dataset with the medical community.”
COPENHAGEN, Denmark; October 28, 2026 * Phase 3 LiGeR-HN1 trial of Petosemtamab in combination with pembrolizumab versus pembrolizumab alone met both primary endpoints, reducing the risk of death by 50% in patients with PD-L1 positive head and neck squamous cell carcinoma (HNSCC), regardless of HPV status * Genmab plans to engage global regulatory authorities and will submit full results for presentation at a future medical meeting 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.
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