NEW YORK – China's National Medical Products Administration (NMPA) on Sunday approved Iaso Bio and Innovent Biologics' autologous CAR T-cell therapy Fucaso (equecabtagene autoleucel) for relapsed or refractory multiple myeloma patients.
The Chinese regulators approved the B-cell maturation antigen (BCMA)-directed CAR T-cell therapy for patients who have received at least three prior treatments, including a proteasome inhibitor and an immunotherapy agent.
The autologous cell therapy, codeveloped by Iaso and Innovent, involves harvesting patients' T-cells, engineering them to target BCMA, and then reinfusing them as a one-time treatment. During the engineering stage, patients' cells are transduced with a lentiviral vector containing a CAR structure with a fully human single chain variable fragment, CD8a hinger, and transmembrane 4-1BB co-stimulatory and CD3ζ activation domains.
The NMPA approved the treatment based on results from the Phase I/II FUMANBA-1 study, in which there was a 96 percent response rate among 101 evaluable relapsed or refractory multiple myeloma patients who received Fucaso. The stringent complete response or complete response rate was 74.3 percent, and the median time to response was 16 days. Ninety-five percent of patients were minimal residual disease-negative, including all who experienced a stringent complete response or complete response on Fucaso. After one year, 78.8 percent of patients were alive without their cancers progressing.
Out of 103 patients in the safety evaluation, just one patient experienced grade 3 or higher cytokine release syndrome, and two patients experienced grade 1 to grade 2 immune effector cell-associated neurotoxicity syndrome (ICANS).
Fucaso is Iaso's first commercialized product and, according to the firm, it is also the first BCMA-targeted CAR T-cell therapy for multiple myeloma approved in China.
While the FUMANBA-1 study took place in China, the US Food and Drug Administration cleared an investigational new drug application in December 2022 giving Iaso and Innovent the go-ahead to conduct trials of the CAR T-cell therapy in the US, too.