WASHINGTON (dpa-AFX) - Genmab A/S (GMAB) reported positive results form a Phase 3 trial evaluating Petosemtamab plus Keytruda (pembrolizumab) as a first-line treatment for patients with PD-L1 positive recurrent or metastatic head and neck cancer. The combination significantly improved overall survival and tumor response compared with pembrolizumab alone.
Head and neck squamous cell carcinoma (HNSCC) is a cancer that develops in the lining of the mouth, throat and voice box. Recurrent or metastatic disease refers to cancer that has returned or spread to other parts of the body.
In the first interim analysis of the LiGeR-HN1 trial, which compared the combination with pembrolizumab alone in a randomized, open-label study, the combinaiton reduced the risk of death by 50% (hazard ratio 0.50; p<0.0001) and significantly improved the objective response rate, meeting both primary endpoints. The survival benefit was observed regardless of human papillomavirus (HPV) status.
Petosemtamab is an investigational bispecific antibody designed to target two proteins, EGFR and LGR5, on tumor cells.
The combination was generally well tolerated, with no new safety signals identified. Petosemtamab is an investigational bispecific antibody designed to target EGFR and LGR5 proteins on tumor cells. Its safety and efficacy have not been established.
Genmab plans to engage global regulatory authorities and present the full trial result at a future medical meeting.
The company is also evaluating Petosemtamab in Phase 3 trial for later-line head and neck cancer and previously treated colorectal cancer.
GMAB has traded between $23.62 and $56.62 over the past year. The stock is currently trading at $57.53, up 28.89%.
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