Xencor announced updated Phase 1 results for XmAb819, selecting 400 mcg/kg as the proposed recommended Phase 3 dose for advanced clear cell renal cell carcinoma (ccRCC). The company confirmed its cash position is sufficient to fund research and development programs and operations into 2029, supporting the planned initiation of a registration-enabling study by late 2027.
Key Highlights
- Achieved a 45.5% confirmed objective response rate (cORR) at the 400 mcg/kg dose in a heavily pre-treated patient population.
- Reported an 82% six-month progression-free survival (PFS) estimate, with the median PFS not yet reached for the target dose cohort.
- Demonstrated favorable tolerability with a low 5.9% discontinuation rate due to treatment-related adverse events.