China’s National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for FUCASO® from IASO Bio. It’s the first fully-human BCMA-directed chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
The NDA approval was based on the results from the FUMANBA-1 clinical study (CTR20192510, NCT05066646). Autoleucel demonstrated remarkable efficacy and favorable safety profiles.
Among the 101 evaluable patients, the overall response rate (ORR) was 96%, and the stringent complete response/ complete response (sCR/CR) rate was 74.3%. Median time to response (mTTR) was only 16 days, and the 12-month PFS rate was 78.8%. 95% of the patients achieved minimal residual disease (MRD) negativity, and all sCR/CR patients achieved MRD negativity. Of the 12 patients with prior CAR-T therapy, 9 achieved CR, and 5 achieved sCR (including 4 patients that sustained sCR for over 18 months post-infusion). In 89 patients without prior CAR-T therapy, 78.7% reached sCR/CR.
Of the 103 patients, only one experienced grade ≥3 cytokine release syndrome (CRS), and 2 experienced grade 1-2 immune effector cell-associated neurotoxicity syndrome (ICANS). All patients with CRS or ICANS recovered after the treatment.
Equecabtagene Autoleucel was still detectable in 50% and 40% respectively of the patients who completed 12-month and 24-month follow-ups after infusion. Only 19.4% of the patients were anti-drug antibody (ADA)-positive after Equecabtagene Autoleucel infusion.
The Principal Investigators of FUMANBA-1 study, Prof. Lugui Qiu, MD, Chinese Academy of Medical Science Hematology Hospital, and Prof. Chunrui Li, MD, PhD, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology: “There’s a significant unmet clinical need for the treatment of multiple myeloma (MM) in China. As a fully-human BCMA CAR-T therapy, FUCASO® has demonstrated remarkable efficacy, with evidence of deep and durable response for high-quality survival for MM patients. We believe that FUCASO’s® approval will offers clinicians a novel breakthrough option benefiting patients with later-line RRMM.”
Sourcea: Prnewswire