Petosemtamab combination cuts risk of death by 50% in Phase III head and neck cancer trial

Genmab has reported positive topline Phase III results showing that petosemtamab combined with pembrolizumab significantly improved overall survival and tumour response in patients with first-line PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma.

The findings come from the global LiGeR-HN1 study, which compared the chemotherapy-free petosemtamab combination with pembrolizumab alone.

At the first prespecified interim analysis, the trial met both of its primary endpoints of overall survival and objective response rate.

Petosemtamab plus pembrolizumab reduced the risk of death by 50% compared with pembrolizumab alone.

The overall survival hazard ratio was 0.50, with a 95% confidence interval of 0.37 to 0.67 and a p value below 0.0001.

The combination also significantly improved objective response rate.

The odds of achieving a tumour response were more than three times higher with petosemtamab plus pembrolizumab than with pembrolizumab alone, producing an odds ratio of 3.17.

The benefit was observed regardless of patients’ HPV status.

Petosemtamab is an investigational IgG1 bispecific antibody designed to simultaneously target epidermal growth factor receptor and leucine-rich repeat-containing G-protein-coupled receptor 5, also known as EGFR and LGR5.

The Phase III LiGeR-HN1 trial enrolled patients receiving first-line treatment for PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma.

An independent data monitoring committee assessed the first interim analysis.

Everett E. Vokes, MD, Chair of the Department of Medicine and Physician-in-Chief at University of Chicago Medicine, said the results demonstrate the potential of a chemotherapy-free combination to improve first-line outcomes in recurrent or metastatic head and neck cancer.

He said meeting both primary endpoints at the first interim analysis was particularly notable given the need for new treatment approaches in this setting.

The safety profile of petosemtamab combined with pembrolizumab was generally consistent with the previously reported safety profiles of the individual medicines.

No new safety signals were identified.

Jan van de Winkel, PhD, Chief Executive Officer of Genmab, said the findings represent an important milestone in the development of petosemtamab and support its potential as a new treatment option for patients with recurrent or metastatic head and neck cancer.

Genmab plans to discuss the results with regulatory authorities globally.

The company also intends to present the full LiGeR-HN1 dataset at a future medical meeting.

Petosemtamab is being evaluated in several additional Phase III studies.

The LiGeR-HN2 trial is assessing the treatment in second- and third-line recurrent or metastatic head and neck squamous cell carcinoma.

Two further studies, LiGeR-CRC1 and LiGeR-CRC2, are evaluating petosemtamab in previously treated recurrent, unresectable or metastatic colorectal cancer.

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Related Topics and Keywords

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