▎WuXi AppTec Content Team Report

Idecabtagene Vicleucel Injection is a CAR-T cell therapy targeting B-cell maturation antigen (BCMA). It uses lentivirus as a gene vector to transfect autologous T cells. The CAR comprises a fully human scFv, CD8a hinge and transmembrane, 4-1BB co-stimulatory, and CD3ζ activation domains. This product was approved in China for treatment in June 2023.Patients with Multiple Myeloma。

FUMANBA-1 is a single-arm, open-label Phase 1b/2 registrational clinical study conducted across 14 centers. It aims to evaluate the efficacy and safety of IASO Bio's fully human BCMA-targeted CAR-T cell therapy, Equecabtagene Autoleucel Injection, in patients with relapsed/refractory multiple myeloma (R/R MM) who have previously received three or more lines of therapy.

This timeJAMA 0ncologyPublished clinical research data on 103 subjects who received Inferylcabtagene Autoleucel Injection as of September 9, 2022. The median follow-up time for the subjects was 13.8 (range 0.4-27.2) months. In terms of efficacy, among the 101 evaluable subjects,Overall Response Rate (ORR) was 96.0%The strict definition of complete remission/complete remission rate (sCR/CR) was 74.3%.In the 89 subjects who had not previously received CAR-T therapy, the ORR was 98.9%.The CR/sCR rate was 78.7%. Among these 101 subjects, the median time to response was 16 days (range 11-179), and the median duration of response (DOR) and median progression-free survival (PFS) were not reached; the 12-month PFS rate was 78.8%. 95.0% of the subjects achieved minimal residual disease (MRD) negativity, with a median time to MRD negativity of 15 days. All sCR/CR subjects achieved MRD negativity, and the median duration of MRD negativity has not been reached.

In terms of safety, among 103 subjects, 93.2% (96/103) experienced cytokine release syndrome (CRS), the vast majority being grade 1-2 CRS, with only one subject developing grade 3 or higher CRS. Only 1.9% (2/103) of subjects developed immune effector cell-associated neurotoxicity syndrome (ICANS), including one case each of grade 1 and grade 2.

Notably, this research presented an updated data cutoff as of December 31, 2022, during the 2023 American Society of Hematology (ASH) Annual Meeting. The median follow-up time increased to 18.07 months. Among 103 evaluable subjects, the overall ORR was 96.1%, with a stringent complete response/complete response (sCR/CR) rate of 77.7%. All subjects achieving CR or higher showed a 100% MRD negativity rate. In 91 subjects who had not previously received CAR-T therapy, the ORR reached 98.9%, the sCR/CR rate was 82.4%, and the minimal residual disease (MRD) negativity rate was 97.8%. At 12 months post-infusion, 81.7% of subjects maintained MRD negativity, and the 12-month PFS rate was 85.5%. Additionally, the IASO Bio’s injectable product persisted long-term in vivo; at 12 months post-infusion, 50% of subjects still had vector copy numbers (VCN) above the detection limit, and at 24 months, 40% of subjects still showed detectable VCN persistence.

IASO Bio's press release stated that the company is also actively developing and advancing the Icaritin injection.Frontline IndicationsUsed for treatmentPatients with multiple myeloma (MM) who have previously received 1-2 lines of treatmentThe Phase 3 clinical study FUMANBA-3. We look forward to these clinical studies based on Chinese patients achieving positive results as soon as possible, and being used by more patients at an early date.

References:

[1] JAMA Oncology Publishes Phase 1b/2 Clinical Study Data of Ixcellen Injection (Fucosun®) for the Treatment of Relapsed/Refractory Multiple Myeloma. Retrieved Nov 08, 2024, from https://mp.weixin.qq.com/s/8YLBrYLY8aNDPJH6NTmpGw