IASO Bio Showcased Optimal Lymphodepletion Outcomes for Equecabtagene Autoleucel in Relapsed Refractory Multiple Myeloma at 2024 IMS Meeting

SHANGHAI and NANJING, China and SAN JOSE, Calif, Sept. 29, 2024 -- IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical firm focused on innovative cell therapy and antibody solutions, recently shared findings from its FUMANBA-1 study during the 2024 International Myeloma Society (IMS) Annual Meeting. The study analyzed the clinical outcomes of patients with relapsed/refractory multiple myeloma (R/R MM) who received the fully human anti-BCMA CAR-T cell therapy, Equecabtagene Autoleucel (Eque-cel, Fucaso™), under varying lymphodepletion regimens. The data revealed that a complete lymphodepletion dose significantly improves remission depth and duration, enhances progression-free survival, and does so without increasing treatment-related toxicity.

This post-hoc analysis included 91 subjects with no prior CAR-T treatment, who were treated with Eque-cel. The median follow-up period was 18.07 months. Among these subjects, 33 received an adjusted lymphodepletion dose, while 58 received the standard dose. Both groups had comparable baseline characteristics, such as age range, physical fitness scores, tumor staging, high-risk cytogenetic abnormalities, and previous treatment lines.

Efficacy results showed that the overall response rate (ORR) and stringent complete remission rate (sCR) were 100% and 82.8% in the standard-dose group, compared to 97% and 78.8% in the dose-adjusted group. Depth of remission and long-term prognosis were superior in the standard-dose group, with 92.2% of patients maintaining a duration of response (DOR) exceeding one year, compared to 70.6% in the dose-adjusted group. The median time to achieve minimal residual disease (MRD) negativity was shorter in the standard-dose group at 15 days, compared to 22 days in the dose-adjusted group. The 12-month MRD negativity rate was significantly higher in the standard-dose group at 90.4%, compared to 63.7% in the dose-adjusted group (HR=3.33, P=0.0166).

For the 12-month progression-free survival (PFS) rate, the standard-dose group achieved 92.2%, with a median PFS not yet reached, while the dose-adjusted group had a 12-month PFS of 73.5% and a median PFS of 30.28 months (HR=3.64, P=0.0032). This trend was also observed among patients receiving a 90% dose adjustment.

Safety analysis indicated no significant differences in the incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) between the two groups. CRS (grades 1-2) occurred in 94.8% of the standard-dose group and 93.9% of the dose-adjusted group, with no severe CRS (≥grade 3) in either group. Apart from one grade 2 ICANS case in the adjusted group, no ICANS (≥grade 3) was reported in either group.

The study concludes that lymphodepletion prior to CAR-T cell therapy is vital for achieving optimal efficacy. The appropriate lymphodepletion regimen is crucial for the effectiveness of Eque-cel treatment, significantly enhancing treatment outcomes and prognosis. When patients can tolerate it, administering the full lymphodepletion dose, if possible, leads to greater benefits without increasing toxicity.

Professor Lugui Qiu from the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, and Professor Chunrui Li from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, emphasized the importance of a standardized and sufficient lymphodepletion regimen for CAR-T cell therapy. These findings provide a scientific basis to ensure the efficacy and safety of CAR-T cell therapy through optimized lymphodepletion regimens, ultimately leading to longer survival and improved quality of life for patients with R/R MM.

Dr. Yongke Zhang, Chief Scientific Officer of IASO Bio, expressed enthusiasm over the findings from the FUMANBA-1 study, which highlight the essential role of standard lymphodepletion in enhancing treatment outcomes and prognosis for patients. These results will help establish and optimize lymphodepletion preconditioning standards in CAR-T cell therapy, aiming to standardize industry practices and ensure patients receive more effective and efficient treatment plans.

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