Xencor reports 25% ORR for XmAb819 in ccRCC Phase 1; dose-expansion cohort selected

Xencor Inc

XmAb819 (ENPP3 x CD3) Phase 1: 25% ORR (5/20 PRs) and 70% DCR in target dose range in heavily pre-treated ccRCC.
All 5 responders remain on treatment; 50% (10/20) of evaluable patients in target range remain on treatment as of Sep 19, 2025.
Safety: CRS (Grade 3 in 4% with correct priming dose), no ICANS, no Grade 5 events; priming dose errors identified and remediated.
First dose-expansion cohort enrolled; expect Phase 3 dose selection in 2026, pivotal study start in 2027.
Early XmAb541 (CLDN6 x CD3) data also presented in ovarian, endometrial, and germ cell tumors.

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