IASO Bio Presents First-in-Class Fully Human BCMA CAR-T Therapy Equecabtagene Autoleucel for High-Risk Newly Diagnosed Multiple Myeloma at EHA 2024
IASO Biotechnology
Cancer Treatment New Drug Developer
June 15, 2024, Nanjing, Shanghai, China, and San Jose, California – IASO Bio, a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative cell therapies, presentedClinical Data of Ixcellen Injection, the World's First Approved Fully Human CAR-T Product, for the Treatment of High-Risk Newly Diagnosed Multiple Myeloma (NDMM) Patients Unsuitable for Transplant。
Report Title：Idecabtagene Vicleucel Injection, a novel fully human BCMA-targeted CAR-T cell therapy for the treatment of high-risk newly diagnosed multiple myeloma patients
Report Type: Oral Report
Report Time:June 15, 2024, 16:30 - 17:45 (CEST)
Reporting Location：Madrid, Spain
Abstract Number：S206
Reporter：Professor Chen Bing from Nanjing Drum Tower Hospital
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 third cycle of induction therapy, 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 an infusion dose of 1×10.6 CAR-T/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, and 12.5% were triple-hit; 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:The median follow-up time after infusion of Icaroten-cel Injection was 7.46 (range: 2.8-18.1) months, and the median PFS has not yet been reached.The 12-month PFS rate was 84.4% (95% CI: 49.31-96.00), with 100% of subjects achieving MRD negativity., where 71.4% (95% CI: 25.8-92.0) of subjects maintained MRD negativity for more than 12 months;The objective response rate (ORR) was 100%, with 93.8% achieving stringent complete response (sCR).。
Safety:The incidence rate of Grade 1-2 cytokine release syndrome (CRS) after the infusion of Icarus Bio's IASO-101 injection 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 of CRS onset was Day 7 (range: 2-9) post-infusion, and the median duration of CRS was 3 (range: 1-8) days. The most common drug-related adverse events of Grade 3 or higher were decreased blood cell counts, with an incidence rate of Grade 3 or higher infectious disease adverse events at 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 IL-6 and CRP after infusion were Day 7 and Day 10, respectively, while serum ferritin levels showed no significant changes.
Professor Chen Bing from Nanjing Drum Tower HospitalStated: "High-risk newly diagnosed multiple myeloma (NDMM) patients have a poor prognosis with standard first-line treatment. For high-risk NDMM patients ineligible for autologous stem cell transplantation (ASCT), Icaritin Injection has demonstrated superior efficacy and safety, achieving deep and sustained remission. All patients achieved minimal residual disease (MRD) negativity, offering a new approach to reversing the poor prognosis of high-risk myeloma patients. Moreover, compared to relapsed/refractory multiple myeloma (RRMM) patients, Icaritin treatment in high-risk NDMM patients showed a lower incidence and severity of cytokine release syndrome (CRS), indicating more favorable safety. Further evidence of the clinical benefits of Icaritin Injection for high-risk NDMM patients will be confirmed through longer-term follow-up."
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Professor Lijuan Chen from Jiangsu Provincial People's Hospital"IASO Bio's Equecabtagene Autoleucel, as a novel fully human BCMA CAR-T therapy, has demonstrated encouraging efficacy and safety in high-risk, newly diagnosed multiple myeloma patients who are ineligible for transplant. This marks the first international report of CAR-T therapy being applied as a first-line treatment in this specific population. For newly diagnosed multiple myeloma patients who are not eligible for transplant, the use of CAR-T therapy as a first-line treatment is expected to further improve response rates and prolong survival compared to traditional chemotherapy and other targeted drug treatments, enhancing patient outcomes. This highlights the potential application of Equecabtagene Autoleucel Injection in frontline MM treatment. Moving CAR-T therapy to the first line will provide patients with more diverse and promising treatment options. With further research and continuous improvement in treatment strategies, we look forward to CAR-T therapies benefiting more patients in the future."
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