Merus Starts Phase 3 Trial Evaluating Petosemtamab with Pembrolizumab in 1L r/m HNSCC

  Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that the first patient has been dosed in the Company’s phase 3 trial evaluating the efficacy and safety of petosemtamab, a Biclonics® targeting EGFR and LGR5, in combination with pembrolizumab, compared to pembrolizumab as first line (1L) therapy for patients with PD-L1+ recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC), referred to as the LiGeR-HN1 trial.

Merus has confirmed through feedback with the U.S. Food and Drug Administration (FDA) that petosemtamab 1500 mg every two weeks is appropriate for further development in HNSCC as monotherapy, and in combination with pembrolizumab.

“Based on our strong phase 2 clinical data reported previously for petosemtamab in HNSCC both as monotherapy and in combination with pembrolizumab, I continue to be confident that petosemtamab has the opportunity to become a new standard of care across r/m HNSCC and potentially beyond,” said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. “Our recently announced alignment with the FDA on phase 3 dose, and excellent execution to date has allowed us to promptly initiate our registration trials in 1L and 2/3L HNSCC.” \

More details of the trial can be found at clinicaltrials.gov. 

https://www.globenewswire.com/news-release/2024/09/30/2955131/37568/en/Merus-Announces-First-Patient-Dosed-in-LiGeR-HN1-a-Phase-3-Trial-Evaluating-Petosemtamab-in-Combination-with-Pembrolizumab-in-1L-r-m-HNSCC.html