Innovent Biologics, Inc. (HKG: 1801) and IASO Biotherapeutics have announced that they have received marketing approval from the National Medical Products Administration (NMPA) for their jointly developed and commercialized product, Fucaso (equecabtagene autoleucel). This approval positions Fucaso as the first fully-human BCMA-directed chimeric antigen receptor (CAR) T cell therapy approved to treat relapsed or refractory multiple myeloma (r/r MM) in patients who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
Equecabtagene Autoleucel: A BCMA-Directed CAR T Cell Therapy
Equecabtagene autoleucel is a BCMA-directed CAR T cell therapy that utilizes a lentivirus as the gene vector to transfect autologous T cells. The CAR comprises a fully-human scFv, CD8a hinge and transmembrane, and 4-1BB-mediated co-stimulation and CD3ζ activation domains. Through rigorous molecular structure selection and screening, along with comprehensive in vivo and in vitro evaluations, the drug has shown rapid and potent efficacy, as well as prolonged persistency in r/r MM patients, leading to more durable and stronger responses and long-term clinical benefits.
Clinical Study Results and Approval Basis
The drug’s approval was based on the results of the FUMANBA-1 clinical study (CTR20192510, NCT05066646), a multi-center Phase I/II registrational clinical trial conducted in China to evaluate the efficacy of equecabtagene autoleucel in patients with r/r MM. Updated data from this ongoing study was presented at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO), demonstrating 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%. The median time to response (mTTR) was only 16 days, and the 12-month PFS rate was 78.8%. A total of 95% of the patients achieved negative minimal residual disease (MRD), and all sCR/CR patients achieved MRD negative status. 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.
Safety data showed that 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 treatment. Equecabtagene autoleucel was still detectable in 50% and 40% of the patients who completed 12-month and 24-month follow-ups after infusion, respectively. Only 19.4% of the patients were anti-drug antibody (ADA)-positive after equecabtagene autoleucel infusion.-Fineline Info & Tech
