Ficerafusp Alfa Plus Pembrolizumab Demonstrated Differentiated Three-Year Overall Survival and Deep Responses Driven by TGF-β Inhibition in 1L R/M HPV-Negative HNSCC
Bicara Therapeutics reported three-year follow-up data from its Phase 1b study of ficerafusp alfa plus pembrolizumab in first-line recurrent/metastatic HPV-negative head and neck cancer. At the pivotal dose of 1500mg weekly, the combination achieved an estimated 31% overall survival rate, approximately doubling the survival rate observed in retrospective analyses of standard of care. Deep responses (≥80% tumor shrinkage) were observed in 80% of responders at the 1500mg dose, with a median duration of response of 21.7 months and median progression-free survival of 9.9 months.
Key figures
- Drug Name
- ficerafusp alfa
- Phase Of Trial
- Phase 1b
- Or R 750mg
- 57%
- Or R 1500mg
- 54%
- Or R 2000mg
- 48%
- Cr rate 750mg
- 13%
- Cr rate 1500mg
- 25%
- Cr rate 2000mg
- 30%
- Median dor 1500mg
- 21.7 months
- Median pfs 1500mg
- 9.9 months
- Median pfs 2000mg
- 12.7 months
- Os rate 3yr 1500mg
- 31%
- Deep response rate 1500mg
- 80%
- Deep response rate 2000mg
- 77%
AI analysis
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