Merus Receives the US FDA’s Breakthrough Therapy Designation for Petosemtamab to Treat 1L PD-L1+ Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
Shots:
- The US FDA has granted BTD to petosemtamab + Keytruda as 1L treatment of r/m HNSCC harboring PD-L1 (CPS ≥ 1) in adults
- BTD was backed by interim data from ongoing P-I/II trial evaluating petosemtamab + Keytruda in mentioned pts that showed 67% response rate in 24 evaluable pts with further data presented at ASCO 2024
- Petosemtamab is also being evaluated in P-III (LiGeR-HN1) trial in combination with Keytruda vs Keytruda in ~500 pts with 1L PD-L1+ r/m HNSCC (1EPs: ORR & OS; 2EPs: DOR & PFS) & P-III (LiGeR-HN2) assessing petosemtamab vs methotrexate/docetaxel/cetuximab in ~500 pts with 2/3L r/m HNSCC (1EPs: ORR & OS; 2EPs: DOR & PFS)
Ref: Merus | Image: Merus
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
