Merus (MRUS) 24th Annual Needham Virtual Healthcare Conference summary

Strategic priorities and innovation

• Focused on advancing multispecific antibody therapies in oncology, leveraging established monoclonal antibody methods for reliability and manufacturability.

• Key assets include FDA-approved zenocutuzumab and clinical-stage petosemtamab and MCLA-129, with ongoing data expected from partners.

• Emphasis on global manufacturing capabilities and robust clinical development processes.

• Current efforts are concentrated on enrolling two phase three trials in recurrent metastatic head and neck cancer.

Clinical data and efficacy highlights

• Petosemtamab showed a 36% response rate and 11.5-month overall survival in second-line head and neck cancer, outperforming historical controls.

• Combination with pembrolizumab in first-line setting yielded a 67% response rate, with durable responses and manageable safety profile.

• Responses observed across all subgroups, including HPV-positive and various PD-L1 expression levels.

• Dose established at 1,500 mg every two weeks, with no need for further dose-ranging studies.

Regulatory and trial strategy

• Both first- and second/third-line phase three trials are ongoing, with over 100 and 90 sites open, respectively.

• Accelerated approval is being pursued based on early endpoints like overall response rate, with survival data to confirm benefit.

• Trials are expected to be substantially enrolled by year-end, with a focus on timely execution.

• Regulatory discussions have centered on the entire patient population, not just HPV subsets.