Innovent Biologics, Inc. and IASO Biotechnology have announced that the China National Medical Products Administration (NMPA) has approved a New Drug Application (NDA) for FUCASO (Equecabtagene Autoleucel).
FUCASO is the first fully BCMA-directed human T-cell chimeric antigen receptor (CAR) therapy for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three previous lines of therapy, including proteasome inhibitors and immunomodulatory agents.
FUCASO (Equecabtagene Autoleucel) is a BCMA-directed CAR T-cell therapy, using lentivirus as a gene vector to transfect autologous T cells. CAR contains fully human scFv, CD8a hinge and transmembrane, and 4-1BB-mediated CD3ζ activation and co-stimulation domains.
Based on molecular structure selection and screening, and in vivo and in vitro evaluations, FUCASO has demonstrated rapid and robust efficacy and prolonged persistence in RRMM patients, providing higher and deeper responses and long-term clinical benefit. Innovent and IASO Bio are responsible for the joint development and commercialization of FUCASO for the treatment of RRMM in China.
NDA approval is based on results from the FUMANBA-1 clinical study, a multi-center registered phase I/II clinical trial conducted in China to evaluate the efficacy of Equecabtagene Autoleucel in patients with RRMM.
A total of 103 subjects received a dose of 1.0×106 CAR-T cells/kg, with a mean follow-up time of 13.8 months.
Among the 101 evaluable patients, the overall response rate (ORR) was 96%, and the complete response/strict response (sCR/CR) rate was 74.3%. The median time to response (mTTR) was 16 days, and the 12-month PFS rate was 78.8%. 95% of patients achieved negative residual disease (MRD), and all sCR/CR patients achieved negative MRD. Of the 12 patients on prior CAR-T therapy, nine achieved CR, and five achieved sCR (including 4 patients who maintained their sCR for more than 18 months post-infusion). In 89 patients without prior CAR-T therapy, 7% achieved sCR/CR.
Of the 103 patients, only one had grade ≥3 cytokine release syndrome (CRS), and two had 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 patients completing follow-up 12 months and 24 months after infusion, respectively. Only 19.4% of patients were positive for anti-drug antibody (ADA) after infusion of Equecabtagene Autoleucel.
FUMANBA-1 study lead investigators, Lugui Qiu, Chinese Academy of Medical Science Hematology Hospital, and Chunrui Li, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, said: “There is a significant unmet clinical need for this treatment. multiple myeloma (MM) in China. As a fully humanized BCMA CAR-T therapy, FUCASO has demonstrated remarkable efficacy, with evidence of deep and long-lasting response for high-quality survival for MM patients. We believe that the FUCASO approval offers clinicians a new breakthrough option that benefits patients with next-line RRMMs.”
Hui Zhou, senior vice president of Innovent Biologics, said: “Multiple myeloma is a common haematological malignancy with a high incidence rate, and recurrence and refractoriness are almost unavoidable after current treatment. There is an urgent unmet need of a well-tolerated and long-lasting treatment for RRMM patients in China. FUCASO, as an innovative fully human BCMA-directed T-cell therapy, has demonstrated strong, long-lasting efficacy and outstanding safety in long-term follow-up data from enrollment clinical studies, underscoring its potential to be a pioneering treatment option for patients with RRMM. . We are very pleased with FUCASO’s approval and look forward to benefiting RRMM patients as the first BCMA CAR-T therapy approved in China.”
Jinhua Zhang, chairman and chief executive of IASO Bio, added: “We are very pleased that FUCASO is approved as a new drug, which is an important milestone for our team. FUCASO is not only the first commercial product of IASO Bio but also the first commercially available human CAR-T therapy in the world. In addition, FUCASO is the first CAR-T cell therapy to be self-developed and independently produced in China as well as the first BCMA CAR-T product approved in China and the first cell therapy approved for the treatment of MM in China. NDA NMPA approval of FUCASO will help us achieve our strategic goal of bringing innovative treatment options, as well as new hope for potential cures, to MM patients in need.”
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