FCARH143, a fully human BCMA-targeted CAR-T, demonstrated a 100% overall response rate in relapsed/refractory multiple myeloma (RRMM) patients, including 64% stringent complete response.
Long-term follow-up of 5+ years showed sustained median progression-free survival of 15.5 months and overall survival of 32.1 months.
Safety profile was manageable with no treatment-related deaths, and cytokine release syndrome and neurotoxicity rates were consistent with CAR-T therapies.
Response rates were independent of disease burden or high-risk cytogenetics, supporting further development in high-risk RRMM populations.