Merus N.V. announced on May 22, 2025, robust interim clinical data from its ongoing Phase 2 trial of petosemtamab in combination with pembrolizumab. The data, with a February 27, 2025 cutoff, was presented at the 2025 American Society of Clinical Oncology® (ASCO®) Annual Meeting.
The trial demonstrated a 63% response rate among 43 evaluable patients in the first-line treatment of PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC). Key findings included 6 complete responses, 21 partial responses, a 79% overall survival rate at 12 months, and a 9-month median progression-free survival.
These results are considered significantly better than pembrolizumab monotherapy, the control arm of Merus's ongoing Phase 3 trial. The strong efficacy and durability underscore petosemtamab's potential to become a new standard of care in head and neck cancer, if approved, and substantially enhance the likelihood of clinical success.
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