Jan van de Winkel / Genmab (company photo; crop).
Genmab said on October 28 that its experimental antibody petosemtamab, combined with pembrolizumab, reduced the risk of death by 50% compared with pembrolizumab alone in a Phase 3 study of certain patients with recurrent or metastatic head and neck cancer.
The company’s topline announcement said the LiGeR-HN1 trial met both primary endpoints, overall survival and objective response rate, at its first interim analysis. The results concern patients receiving first-line treatment for PD-L1-positive head and neck squamous cell carcinoma, regardless of HPV status.
Petosemtamab remains investigational. Its safety and efficacy have not been established, and the announcement is not a regulatory approval or a change in available treatment. Pembrolizumab is the immunotherapy marketed as Keytruda.
What the interim results show
Genmab reported an overall-survival hazard ratio of 0.50, with a 95% confidence interval of 0.37 to 0.67 and a p-value below 0.0001. The 50% figure describes the relative risk of death during the trial’s follow-up; it does not mean that half of patients were cured or that survival time doubled.
For objective response, the company reported an odds ratio of 3.17, with a 95% confidence interval of 2.06 to 4.89 and a p-value below 0.0001. That measure compares the odds of a response between the treatment groups, rather than showing the percentage of patients whose tumors responded.
The findings were assessed by an independent data monitoring committee. Genmab said the combination’s safety profile was consistent with the previously reported profiles of the two drugs and that no new safety signals were identified. Detailed results, including the full safety dataset, are still to come.
Full data and regulatory discussions are next
LiGeR-HN1 is a randomized, open-label global study comparing petosemtamab plus pembrolizumab with pembrolizumab alone. Patients were assigned in a one-to-one ratio. The trial also tracks progression-free survival, duration and timing of response, safety and patient-reported outcomes.
Petosemtamab is a bispecific antibody designed to bind two targets, EGFR and LGR5. The treatment is intended to interfere with tumor-cell signaling and help the immune system attack tumor cells.
Genmab, led by President and Chief Executive Officer Jan van de Winkel, said it plans to engage regulatory authorities worldwide and submit the full results for presentation at a future medical meeting. Those steps, and review of the complete data, remain ahead.
For patients and families, the finding is a potentially important research development, not a promise of benefit for an individual patient. Decisions about treatment or clinical-trial participation should be discussed with the treating cancer team.
JBizNews Desk | Copenhagen
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