IASO Bio launches fully human BCMA CAR T for multiple myeloma
The launch of FUCASO
The National Medical Products Administration (NMPA) of China has granted approval to IASO Bio's New Drug Application (NDA) for FUCASO®. This represents the inaugural chimeric antigen receptor (CAR) T cell therapy directed towards BCMA in adult patients who have undergone a minimum of three previous treatment courses, including proteasome inhibitors and immunomodulatory agents, and have relapsed or resisted multiple myeloma (RRMM).
The NDA approval was contingent upon the outcomes obtained from the clinical trial FUMANBA-1 (CTR20192510, NCT05066646). Autoleucel exhibited exceptional efficacy and favorable safety profiles.
The overall response rate (ORR) was 96% among the 101 evaluable patients, while the stringent complete response/complete response (sCR/CR) rate was 74.3%. There was a mere 16-day median time to response (mTTR), and the 12-month PFS rate was 78.8%. Minimal residual disease (MRD) negativity was acquired by 95% of the patients, and all sCR/CR patients attained MRD negativity. Fifteen of the twelve patients who had previously received CAR-T therapy attained CR, while five attained sCR (with four of them maintaining sCR for more than eighteen months after infusion). 78% of the 89 patients who had not received CAR-T therapy before achieved sCR/CR.
Out of the total of 103 patients, a mere one developed grade 3 cytokine release syndrome (CRS), while two patients were diagnosed with immune effector cell-associated neurotoxicity syndrome (ICANS) grades 1-2. All CRS and ICANS patients recovered following treatment.
After infusion, equecabtagene Autoleucel remained detectable in 50% and 40% of patients who underwent 24-month and 12-month follow-up, respectively. Following infusion of Equecabtagene Autoleucel, anti-drug antibody (ADA) positivity was observed in only 19.4% of the patients.
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, served as the principal investigators of the FUMANBA-1 study. "In China, the treatment of multiple myeloma (MM) remains a substantial unmet clinical need."
FucasO®, a BCMA CAR-T therapy that is completely human, has exhibited exceptional effectiveness, as evidenced by a profound and long-lasting response that contributes to high-quality survival among patients with MM. It is our conviction that the approval of FUCASO® will provide clinicians with an innovative and transformative option that will benefit patients who are undergoing later-line RRMM.
