Xencor Presents Phase 1 Dose Selection Data for XmAb819, a Potential First-in-Class ENPP3 x CD3 Bispecific T-Cell Engager, in Development for Patients With Advanced Clear Cell Renal Cell Carcinoma and ENPP3+ Tumors
Xencor presented updated Phase 1 data for XmAb819, an ENPP3 x CD3 bispecific T-cell engager, at ESMO 2026, selecting 400 mcg/kg IV as the proposed Phase 3 dose based on a 45.5% confirmed response rate and an 82% 6-month PFS Kaplan-Meier estimate. The company plans to discuss a potential accelerated approval pathway with the FDA in 1H2027 in heavily pre-treated ccRCC subgroups, and to initiate a global randomized trial versus tivozanib that could support full approval in second- and third-line ccRCC. XmAb819 was generally well tolerated, with a 5.9% treatment discontinuation rate due to related adverse events.
Key figures
- Drug Name
- XmAb819
- Phase Of Trial
- Phase 1
- Cash runway
- into 2029
- Corr 400mcg
- 45.5%
- Uorr 400mcg
- 55%
- Proposed rp3d
- 400 mcg/kg IV
- Patients enrolled
- 119
- Expansion dose patients
- 68
- Six month pfs km estimate
- 82%
- Grade3plus related teae rate
- 72.1%
- Accelerated approval fda discussion
- 1H2027
- Discontinuation due to related teae
- 5.9%
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