Xencor selects 400 mcg/kg dose for XmAb819 after Phase 1 shows ~45% response in advanced kidney cancer
Xencor announced that 400 mcg/kg IV will be the proposed Phase 3 dose of its bispecific antibody XmAb819 for clear cell renal cell carcinoma. The Phase 1 expansion cohort reported a confirmed objective response rate of about 45% and an 82% six‑month progression‑free survival rate. The company plans to discuss an accelerated‑approval pathway with the FDA in the first half of 2027 and to launch a global randomized trial versus tivozanib. A webcast will be held to detail the data and development plans.
Why it matters
Xencor says the data support a potential accelerated‑approval discussion with the FDA in H1 2027, which could enable earlier market entry if approved. Selecting a definitive Phase 3 dose also moves the program toward a registration‑enabling trial, affecting future funding and valuation.
Key facts
- 1Xencor selected 400 mcg/kg IV as the proposed recommended Phase 3 dose for XmAb819. stocktitan.net
- 2The 400 mcg/kg expansion cohort showed a confirmed objective response rate of 45.5%. tradingview.com
- 3The same cohort reported a six‑month progression‑free survival estimate of 82%. tradingview.com
- 4The Phase 1 study enrolled 119 patients across 11 dose levels as of September 1 2026. investing.com
- 5Grade 3 or higher treatment‑related adverse events occurred in 72.1% of patients across expansion cohorts. investing.com
- 6Liver enzyme elevations were the most common adverse events, with AST increased in 35.3% and ALT increased in 33.8% of patients. investing.com
Open questions
- Material 1 reports a 45% confirmed ORR, while materials 2 and 3 report 45.5% on the same basis.
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.