Clinical TrialOct 26, 2026, 07:56 AM
Xencor XmAb819 Shows 45.5% cORR in Advanced ccRCC Phase 1 Study
AI Summary
Xencor Inc. announced updated Phase 1 study results for its lead oncology candidate, XmAb819, a novel ENPP3 x CD3 T-cell engaging bispecific antibody, in patients with advanced clear cell renal cell carcinoma (ccRCC). The data presented at the ESMO Congress 2026 showed a confirmed objective response rate (cORR) of 45.5% at the 400 mcg/kg dose, with a 6-month PFS estimate of 82%. The company plans to discuss a potential accelerated approval pathway with the FDA and initiate a global randomized study comparing XmAb819 to tivozanib. Xencor also expects its cash runway to extend into 2029.
Key Highlights
- XmAb819 Phase 1 study in advanced ccRCC shows 45.5% cORR at 400 mcg/kg dose.
- 6-month PFS estimate of 82% observed at 400 mcg/kg dose.
- Xencor plans to discuss accelerated approval pathway with FDA in 1H2027.
- Global randomized study of XmAb819 vs. tivozanib planned.
- Cash runway extends into 2029, supporting continued development.
- Updated Phase 1 results presented at ESMO Congress 2026.
- XmAb819 is an ENPP3 x CD3 T-cell engaging bispecific antibody.
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