Genmab's petosemtamab combination therapy significantly improved survival rates in a Phase 3 head and neck cancer trial, meeting dual primary endpoints and signaling a potential shift in standard care.
Genmab reported positive topline results from the Phase 3 LiGeR-HN1 trial, where the petosemtamab and pembrolizumab combination met dual primary endpoints of overall survival and objective response rate. The treatment demonstrated a 50% reduction in the risk of death compared to pembrolizumab alone, positioning it as a potential first-in-class therapy for first-line PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma. This clinical success serves as a major milestone for the company's late-stage pipeline and supports future regulatory engagement.
The co-primary endpoints were overall survival (OS) and objective response rate (ORR).
No, petosemtamab is an investigational agent and its safety and efficacy have not yet been established.
It is a low-fucose, fully human IgG1 bispecific antibody that targets both EGFR and LGR5 to inhibit tumor signaling and facilitate destruction by innate immune cells.
Genmab A/S reported positive Phase 3 results for its petosemtamab combination therapy in treating head and neck squamous cell carcinoma. The trial met dual primary endpoints, demonstrating a 50% reduction in the risk of death compared to pembrolizumab alone. This milestone positions the bispecific antibody as a potential first-in-class treatment, prompting the company to initiate global regulatory discussions.
The trial demonstrated that petosemtamab, when combined with pembrolizumab, significantly improves survival and response rates for patients with recurrent or metastatic head and neck squamous cell carcinoma, potentially establishing a new chemotherapy-free treatment standard.