IASO Bio Presents Updated Clinical Data of Ixazomib-Based CAR-T Therapy Ixazolumcel (Fucaso®) in High-Risk Newly Diagnosed Multiple Myeloma at EHA 2024

Recently, IASO Bio presented clinical data of the world's first approved fully human CAR-T product, Equecabtagene Autoleucel Injection, for the treatment of high-risk newly diagnosed multiple myeloma (NDMM) patients ineligible for transplant at the 2024 European Hematology Association (EHA) Annual Meeting in an oral presentation format. Abstract Number: S206.

FUMANBA-2 Study is a multi-center, open-label, Phase I, single-arm study initiated by investigators. The principal investigators are Professor Bing Chen from Nanjing Drum Tower Hospital and Professor Lijuan Chen from Jiangsu Provincial People's Hospital. This clinical study aims to explore the efficacy, safety, and pharmacokinetic/pharmacodynamic characteristics of Icaritin Injection in treating high-risk NDMM. Participants need to complete four cycles of induction therapy before infusion of Icaritin Injection. After the end of the third induction treatment cycle, patients assessed by the investigator as unsuitable for autologous hematopoietic stem cell transplantation (ASCT) will undergo peripheral blood mononuclear cell collection and subsequently receive Icaritin Injection treatment at a dose of 1×106 CAR-T cells/kg.

The primary endpoints of this study are the proportion of minimal residual disease (MRD)-negative subjects and progression-free survival (PFS); secondary endpoints include objective response rate (ORR), duration of response (DOR), safety, and pharmacokinetics/pharmacodynamics (PK/PD).

As of January 25, 2024, a total of 16 NDMM subjects with high-risk features were enrolled, of which 62.5% were double-hit type and 12.5% were triple-hit type; 25% of the subjects had extramedullary lesions; 37.5% of the subjects were in R-ISS stage III, 6.3% were in R-ISS stage III with double-hit, and 6.3% were in R-ISS stage III with triple-hit.

Effectiveness:After infusion of IASO Bio's Idecabtagene Vicleucel Injection, the median follow-up time was 7.46 (range: 2.8-18.1) months. The median progression-free survival (PFS) has not been reached yet, and the 12-month PFS rate was 84.4% (95% CI: 49.31-96.00). All 100% of the subjects achieved minimal residual disease (MRD) negativity, with 71.4% (95% CI: 25.8-92.0) maintaining MRD negativity for over 12 months. The objective response rate (ORR) was 100%, with 93.8% achieving stringent complete response (sCR).

Safety:After infusion of Icarus Bio's IASO-102 injection, the incidence rate of Grade 1-2 cytokine release syndrome (CRS) was 68.8%. No Grade 3 or higher CRS was observed, and no immune effector cell-associated neurotoxicity syndrome (ICANS) or other neurotoxicity occurred. The median time to onset of CRS was Day 7 (range: 2-9) post-infusion, with a median duration of 3 (range: 1-8) days. The most common Grade 3 or higher drug-related adverse event was decreased blood cell count, and the incidence rate of Grade 3 or higher infection-related adverse events was 25.0%.

Pharmacokinetics and Pharmacodynamics:The median time to peak CAR copy number in peripheral blood was Day 10 (range: 7-21) post-infusion, with a median peak level of 79,681.299 copies/microgram DNA. In 81.25% of subjects, free B-cell maturation antigen (sBCMA) was cleared within one month post-infusion. The median time to peak levels of cytokines IL-6 and CRP post-infusion were Day 7 and Day 10, respectively, while serum ferritin levels showed no significant changes.

Editor: Liuli

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