Xencor reports 45.5% confirmed response rate for XmAb819 in Phase 1 kidney cancer trial
XNCR•Xencor reported a 45.5% confirmed response rate for XmAb819 at the selected dose in a Phase 1 trial for advanced clear cell renal cell carcinoma. The company selected a proposed Phase 3 dose and plans a potential registration-enabling trial by the end of 2027.
1. Phase 1 results
Xencor selected a proposed Phase 3 dose for XmAb819 following Phase 1 results presented at the ESMO Congress 2026. The treatment showed antitumor activity in heavily pretreated patients with advanced clear cell renal cell carcinoma, and most confirmed responses remained ongoing. Adverse events were generally manageable, though severe events occurred; discontinuations linked to adverse events were uncommon.
2. Next steps
Xencor plans a potential registration-enabling trial comparing XmAb819 with tivozanib by the end of 2027. The company also plans discussions with the FDA about a potential accelerated approval pathway for patients who have exhausted standard treatments.
