Kyntra Bio presents Phase 1b/2 data on FG-3246 with enzalutamide in mCRPC

Kyntra Bio reported that investigator‑sponsored Phase 1b/2 data for FG‑3246 combined with enzalutamide in metastatic castration‑resistant prostate cancer will be presented at ASCO GU; the study included 44 patients and showed a composite response rate of 21% overall and median radiographic progression‑free survival of 7.0 months (10.1 months in patients with one prior ARPI).

Kyntra Bio released results from an investigator‑sponsored Phase 1b/2 study testing FG‑3246 in combination with enzalutamide for metastatic castration‑resistant prostate cancer (mCRPC). The company said the data will be presented at the 2026 ASCO Genitourinary Cancers Symposium in late February. The study enrolled 44 biomarker‑unselected patients and evaluated safety, dose, and anti‑tumor activity. The release also noted that FG‑3246 is being evaluated in a separate Phase 2 monotherapy trial with interim data expected in the second half of 2026. Key findings: - The presentation is scheduled for the ASCO GU poster session on February 26, 2026. - The study cohort included 44 patients; the composite response rate was reported as 21% overall and 40% in patients who had progressed on only one prior androgen receptor pathway inhibitor (ARPI). - Median radiographic progression‑free survival (rPFS) was reported as 7.0 months overall and 10.1 months in the subgroup with one prior ARPI; the Phase 1b dose recommended for Phase 2 was 2.1 mg/kg of FG‑3246 with 160 mg/day of enzalutamide. - Safety observations included neutropenia that was reported as mitigated with prophylactic G‑CSF and common treatment‑related adverse events such as fatigue and peripheral neuropathy; cumulative toxicities led to discontinuation for some patients. Summary: The article reports that investigator‑sponsored Phase 1b/2 data for FG‑3246 plus enzalutamide will be presented at ASCO GU and summarizes key efficacy and safety outcomes from 44 patients. The company also reported that a Phase 2 monotherapy trial of FG‑3246 is ongoing, with interim results expected in the second half of 2026.