Merus’ Petosemtamab Receives the US FDA’s Breakthrough Therapy Designation for Head and Neck Squamous Cell Carcinoma
Shots:
- The BTD was granted to petosemtamab for treating recurrent/metastatic HNSCC progressed post Pt-based CT & anti-PD-1/PD-L1 treatment. It received FTD for the same in Aug 2023. A P-III study in previously treated HNSCC and a P-III trial of petosemtamab + Keytruda in treatment-naïve patients is planned in mid-2024
- The designation was based on the ongoing P-I/II study assessing the efficacy, durability & safety of petosemtamab alone to treat advanced solid tumors incl. recurrent/metastatic HNSCC. Data is anticipated in H2’24
- Petosemtamab is a Biclonics low-fucose IgG1 Ab that targets EGFR & LGR5 and shows EGFR-dependent signal inhibition, LGR5 binding leading to EGFR internalization for cancer cell degradation as well as ADCC & ADCP activities
Ref: Merus | Image: Merus
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.