#ESMO26 🧬 Could B7-H3-targeted ADCs challenge docetaxel in mCRPC?

BNT324-03, phase III TiP evaluating elfetabart drozuntecan (Elfe-D), a B7-H3-directed ADC carrying a topoisomerase I inhibitor payload.

📌Early phase I/II data provide the rationale:
• PSA50: 42.9%
• Confirmed ORR: 35.8%
• Median rPFS: 11.3 months
• Activity also observed after prior ¹⁷⁷Lu-PSMA therapy

📌Phase III design:
• N≈736, randomized 1:1
• Elfe-D 6 mg/kg Q3W vs docetaxel 75 mg/m² Q3W
• Taxane-naïve mCRPC after 1–2 ARPIs
• Prior ¹⁷⁷Lu-PSMA and docetaxel for mHSPC permitted
• Dual primary endpoints: rPFS and OS
@UroToday @myESMO