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Xencor (XNCR) investor relations material
Xencor Study Result summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Study design and patient population
Phase 1, multicenter, open-label, dose-escalation and expansion study of XmAb819 in advanced clear cell RCC, with both IV and SC cohorts; data cut-off September 19, 2025.
69 heavily pretreated patients enrolled, all with prior anti-PD1 and VEGF-TKI therapy; median of 4 prior regimens, 36% had HIF2α inhibitor exposure.
No preselection for ENPP3 expression, but retrospective testing confirmed most were high expressors.
Study objectives include safety, tolerability, pharmacokinetics, and anti-tumor activity using a 3+3+3 dose-escalation design.
Safety and tolerability
XmAb819 was generally well tolerated, with 4% discontinuation due to adverse events and over 90% reaching target dose.
Most common adverse events were CRS, rash, and GI toxicities, mainly Grade 1 or 2; Grade 3 CRS was 4% with correct dosing.
No treatment-related ICANS or Grade 5 events; most adverse events were manageable and transient.
Dose prep errors led to higher Grade 3 CRS rates (28% in error group vs 4% with correct prep); mitigated by site retraining and new formulation planned for 2026.
Grade 3 treatment-related events included rash (16%) and liver enzyme elevations (7%); one dose-limiting Grade 4 liver enzyme elevation.
Efficacy and clinical activity
In the target dose range, XmAb819 showed a 25% objective response rate (all partial responses) and 70% disease control rate in heavily pretreated patients.
Majority of patients experienced tumor reduction, with sustained disease control and some deepening responses over time.
Responses included patients with prior progression on belzutifan and those with low ENPP3 expression.
50% of efficacy-evaluable patients in the target dose range remain on treatment; all five responders remain on therapy.
One patient with initial progression had a 47% reduction in lesions and remains on treatment.
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