Kyntra Bio Announces Positive Data from the Investigator-Sponsored Phase 1b/2 Study of FG-3246 in Combination with Enzalutamide in Patients with Metastatic Castration Resistant Prostate Cancer to Be Presented at ASCO GU 2026

Core Viewpoint - Kyntra Bio announced promising preliminary data on the anti-tumor activity of FG-3246 in combination with enzalutamide for patients with metastatic castration-resistant prostate cancer (mCRPC), with results to be presented at the 2026 ASCO GU symposium [1][2] Study Results - The Phase 1b/2 study showed a composite response rate of 21% in the overall cohort and 40% in patients who had progressed on only one prior androgen receptor pathway inhibitor (ARPI) [3] - Median radiographic progression-free survival (rPFS) was 7.0 months in the overall cohort, with a notable 10.1 months in patients who had only one prior ARPI [3][4] - Higher tumor uptake of FG-3180 indicated a trend towards a higher probability of PSA50 response (p=0.053), suggesting its potential as a biomarker for patient selection [3][4] Safety Profile - The combination therapy of FG-3246 and enzalutamide exhibited a safety profile similar to that observed in previous trials, with neutropenia risk mitigated through G-CSF prophylaxis [4][5] - Common treatment-related adverse events (TRAEs) included fatigue, peripheral neuropathy, anorexia, and dysgeusia, with some patients discontinuing treatment due to cumulative toxicities [5] Future Developments - Kyntra Bio is on track to provide interim analysis results from the Phase 2 monotherapy trial of FG-3246 in the second half of 2026, which will further explore the utility of FG-3180 as a patient selection biomarker [4][6] - FG-3246 is being developed as a first-in-class antibody-drug conjugate targeting CD46, with potential applications in other tumor types beyond mCRPC [7][9]