Kyntra Bio’s FG-3246 Combo Achieves 10.1-Month rPFS in mCRPC
Kyntra Bio’s investigator-sponsored Phase 1b/2 trial of FG-3246 plus enzalutamide in 44 mCRPC patients showed a median rPFS of 7.0 months overall and 10.1 months in patients with only one prior ARPI. High FG-3180 tumor uptake correlated with greater PSA50 response probability, and neutropenia was managed successfully with G-CSF.
1. Study Results
In the investigator-sponsored Phase 1b/2 trial, 44 mCRPC patients received FG-3246 at 2.1 mg/kg plus 160 mg/day of enzalutamide. The regimen produced a median radiographic progression-free survival of 7.0 months in all patients and extended to 10.1 months in those with only one prior ARPI line.
2. Biomarker Imaging Insights
Baseline PET imaging with FG-3180 revealed that higher tumor uptake showed a trend toward increased probability of PSA50 response (p=0.053), suggesting FG-3180 could serve as a valuable biomarker for selecting patients likely to benefit from FG-3246 therapy.
3. Safety Profile and Next Steps
Combination therapy showed a safety and exposure profile consistent with prior FG-3246 monotherapy, with neutropenia effectively mitigated by G-CSF prophylaxis. Kyntra Bio plans to present these data at the ASCO GU 2026 symposium and expects interim results from the Phase 2 monotherapy trial in the second half of 2026.