Danish biotechnology company Genmab A/S (CPH:GMAB) on Wednesday announced positive topline results from its Phase 3 LiGeR-HN1 trial, showing that petosemtamab combined with pembrolizumab significantly improved overall survival and objective response rates in patients with first-line PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma.

At the first interim analysis, the combination reduced the risk of death by 50% compared with pembrolizumab alone and met both primary endpoints, regardless of human papillomavirus (HPV) status.

The combination was generally well tolerated, with no new safety signals identified and a safety profile consistent with those of the individual agents.

Genmab plans to engage global regulatory authorities and submit the full trial results for presentation at a future medical meeting.

Petosemtamab is also being evaluated in Phase 3 trials for second- and third-line recurrent or metastatic head and neck cancer, as well as previously treated recurrent, unresectable or metastatic colorectal cancer.