Genmab’s head-and-neck cancer combination improves survival in Phase 3 trial

On October 28, Genmab announced positive results from the first interim analysis of LiGeR-HN1, a Phase 3 trial—the late-stage testing typically used to support drug approval. It compared petosemtamab plus pembrolizumab with pembrolizumab alone as the initial treatment for recurrent or metastatic head-and-neck squamous cell cancer, a cancer that has returned or spread. Patients’ tumors expressed PD-L1, a marker used to help select immunotherapy treatment.^[1]

Genmab said the combination met both main trial goals: longer survival and a higher proportion of patients whose tumors substantially shrank, with statistically significant improvements. The interim analysis showed a 50% reduction in the relative risk of death, with a hazard ratio of 0.50 and a 95% confidence interval of 0.37–0.67.^[1] Petosemtamab remains investigational; Genmab plans to engage regulators globally and submit full results for a future medical meeting.^[1]

Adding petosemtamab to the comparison treatment produced a survival benefit, giving doctors and payers stronger evidence to assess the extra drug. If regulators approve it and the full efficacy and safety data support use, adoption could create a new revenue stream for Genmab and increase demand for pembrolizumab-based combination treatment in these patients.^[1]

For companies developing competing head-and-neck cancer treatments, the result could raise the bar: future regimens would need to establish their value through effectiveness, safety or convenience. Genmab shares surged after the announcement, showing investors had begun assigning greater value to the drug’s prospects, while approval and clinical adoption remain necessary steps toward revenue.^[1][2]

Impact