Skip to content Skip to footer

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

Related News:- Merus and Biohaven Join Forces to Advance Three Bispecific ADC Programs

PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com

Sign Up to Our Newsletter

Be the first to know the latest updates

[mc4wp_form id="13387" element_id="style-1"]