Merus (MRUS) Jefferies Global Healthcare Conference 2025 summary

Platform and clinical pipeline overview

• Focus on bispecific and multi-specific antibodies for cancer, leveraging a platform that enables production similar to monoclonal antibodies.

• Technology allows for large-scale screening and high-throughput analysis to select optimal clinical candidates.

• Approved medicine Bizengri and promising clinical data for Petosemtamab in head and neck cancer highlight platform success.

Petosemtamab clinical data and regulatory milestones

• Petosemtamab, a bispecific targeting EGFR and LGR5, showed unprecedented efficacy in head and neck cancer, especially in combination with pembrolizumab.

• Recent ASCO data: 63% response rate and 80% one-year survival in first-line head and neck cancer, far exceeding historical immunotherapy benchmarks.

• FDA granted breakthrough therapy designation for both single-agent and combination settings due to outsized efficacy.

• Efficacy observed across EGFR expression levels; no strong correlation between EGFR or LGR5 expression and response.

• Median progression-free survival reported at nine months, with similar outcomes in HPV-positive and HPV-negative populations.

Phase 3 trial progress and regulatory strategy

• Over 125 sites activated for both first-line and second/third-line phase 3 trials in head and neck cancer, with substantial enrollment expected by year-end.

• Top-line results from one or both phase 3 trials anticipated next year.

• Trials follow FDA's Project FrontRunner framework, allowing for potential accelerated approval based on interim overall response rate and confirmation with survival data.

• Interim analyses will focus on confirmed response rates and durability, with survival trending also considered.