Genmab: Petosemtamab plus pembrolizumab halves mortality in PD‑L1+ R/M HNSCC in Phase 3 interim readout
- LiGeR‑HN1 is a global, randomized, open‑label Phase 3 trial comparing petosemtamab+pembrolizumab to pembrolizumab in first‑line PD‑L1+ recurrent/metastatic HNSCC.
- At first interim analysis, overall survival HR was 0.50 (95% CI 0.37–0.67; p<0.0001), a 50% reduction in risk of death regardless of HPV status.
- Objective response rate met the co‑primary endpoint with an odds ratio of 3.17 (95% CI 2.06–4.89; p<0.0001).
- The combination’s safety was generally well tolerated with no new safety signals; Genmab plans to engage regulators and present the full dataset.
Trial design
LiGeR‑HN1 is a global, randomized, open‑label Phase 3 study assessing petosemtamab plus pembrolizumab versus pembrolizumab alone as first‑line therapy for patients with PD‑L1‑positive recurrent or metastatic head and neck squamous cell carcinoma. Patients were randomized 1:1; co‑primary endpoints are overall survival (OS) and objective response rate (ORR).
Key efficacy results
At the first interim analysis reviewed by an independent data monitoring committee, the petosemtamab combination met both primary endpoints. OS showed a hazard ratio of 0.50 (95% CI, 0.37–0.67; p<0.0001), representing a 50% reduction in the risk of death, and ORR showed an odds ratio of 3.17 (95% CI, 2.06–4.89; p<0.0001). The benefits were reported irrespective of HPV status.
Safety
The safety profile of petosemtamab plus pembrolizumab was described as generally well tolerated and consistent with the known profiles of the individual agents; no new safety signals were identified.
Next steps and broader programme
Genmab intends to engage global regulatory authorities and will submit the full LiGeR‑HN1 results for presentation at a future medical meeting. Petosemtamab is also being evaluated in additional Phase 3 trials, including LiGeR‑HN2 (later‑line HNSCC) and two colorectal cancer studies (LiGeR‑CRC1 and LiGeR‑CRC2).
Source: Genmab