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Merus N.V.’s Phase 3 Study on Petosemtamab: A Potential Game-Changer for HNSCC Treatment

Merus N.V.’s Phase 3 Study on Petosemtamab: A Potential Game-Changer for HNSCC Treatment

Merus NV ((MRUS)) announced an update on their ongoing clinical study.

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Merus N.V. is conducting a Phase 3 clinical study titled ‘A Phase 3 Open-label, Randomized Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared With Investigator’s Choice Monotherapy Treatment in Previously Treated Patients With Incurable, Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma.’ The study aims to assess the efficacy and safety of Petosemtamab, a promising drug for patients with head and neck squamous cell carcinoma (HNSCC) who have previously undergone anti-PD-1 and platinum-based therapies. This study is significant as it targets a challenging patient population with limited treatment options.

The intervention being tested is Petosemtamab, known as MCLA-158, which is an experimental drug. It is compared against the investigator’s choice of monotherapy, which includes drugs like Cetuximab, Methotrexate, and Docetaxel. The purpose of Petosemtamab is to provide a new treatment avenue for patients with advanced HNSCC.

The study is designed as an open-label, randomized, controlled trial with a parallel intervention model. There is no masking involved, and the primary purpose is treatment. Patients are randomly allocated to either the experimental group receiving Petosemtamab or the active comparator group receiving the investigator’s choice of treatment.

The study began on June 25, 2024, with primary completion expected in the future. The last update was submitted on July 28, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates for stakeholders.

This clinical update could potentially influence Merus N.V.’s stock performance positively, as successful results may enhance investor confidence and market position. The competitive landscape includes other pharmaceutical companies developing treatments for HNSCC, making this study’s outcome particularly impactful.

The study is currently recruiting, and further details are available on the ClinicalTrials portal.

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