Xencor selects 400 µg/kg dose for XmAb819 after Phase 1 data show 45.5% response in kidney cancer
+2 new sources since this summary was written
Xencor announced that the 400 µg/kg intravenous dose of its bispecific antibody XmAb819 will be the proposed Phase 3 dose. In the expansion cohort, 45.5% of the 11 patients with evaluable scans experienced tumor shrinkage and an estimated 82% were progression‑free at six months. The company said it will seek accelerated‑approval discussions with the FDA in the first half of 2027 and will launch a global randomized Phase 3 trial versus tivozanib. Management hosted a webcast to outline the data and development plan.
Why it matters
The strong early efficacy and a clear regulatory pathway could lift the drug’s valuation, as analysts at Wedbush and Truist have kept buy ratings and price targets near $30. The announcement also triggered a sharp share rally, giving investors immediate upside.
Key facts
- 1Xencor chose a 400 µg/kg IV dose as the proposed recommended Phase 3 dose (RP3D). stocktitan.net
- 2The confirmed objective response rate was 45.5% among 11 efficacy‑evaluable patients. investing.com
- 3An estimated 82% of those patients were alive without disease progression at six months. investing.com
- 4Grade 3 or higher adverse events were reported in 72.1% of patients. investing.com
- 5Xencor’s stock rose about 15.9% in morning trading after the data were released. investing.com
- 6The company expects its cash resources to fund operations and R&D into 2029. investing.com
Summary written by AlphAI AI Desk from 9 of 9 sources. Not investment advice. Figures are as stated by the linked sources.