IASO Bio Presented Equecabtagene Autoleucel Results for R/RMM Patients with Renal Impairment at 2024 IMS Meeting

SHANGHAI and NANJING, China and SAN JOSE, Calif., Sept. 27, 2024 /PRNewswire/ -- IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on innovative cell and antibody therapies, announced the results of a pivotal phase 2 study, FUMANBA-1, at the 2024 International Myeloma Society (IMS) Annual Meeting. This study evaluated the fully human anti-BCMA CAR-T cell therapy, Equecabtagene Autoleucel (Eque-cel, FucasoTM), specifically in patients with relapsed or refractory multiple myeloma (R/R MM) who also have renal impairment (RI).

The FUMANBA-1 study enrolled 91 subjects who had not previously received CAR-T therapy. These subjects were monitored over a median follow-up period of 18.07 months. Participants were categorized into two groups based on their creatinine clearance (CrCl) levels: an RI group with CrCl between 40 and 70 ml/min, and a non-RI group with CrCl above 70 ml/min. The RI group comprised 28 subjects, while the non-RI group included 63 subjects.

Baseline characteristics between the RI and non-RI groups were similar. The study demonstrated that the RI group responded to the CAR-T therapy as rapidly and profoundly as the non-RI group, achieving comparable long-term efficacy. Safety profiles were also similar between the groups. Both experienced cytokine release syndrome (CRS), though only the non-RI group reported a single case of grade 2 immune effector cell-associated neurotoxicity syndrome (ICANS). The RI group did show a marginally higher occurrence of severe short-term cytopenia, which resolved by day 60.

The study concluded that R/RMM patients with renal impairment could achieve a rapid, deep, and durable response with Eque-cel therapy without compromising safety. The treatment also improved renal function by clearing myeloma cells.

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 significance of these findings. They highlighted that this data dispels the previous concerns regarding the tolerance of R/R MM patients with renal impairment to CAR-T treatments. They noted that Eque-cel induced rapid, deep, and durable remission in this patient population, offering valuable insights for clinical applications.

Dr. Yongke Zhang, Chief Scientific Officer of IASO Bio, expressed satisfaction with the study's results. He stated that the presented data at the IMS Annual Meeting confirmed the promising efficacy and safety of Eque-cel in treating R/RMM patients with renal impairment. Additionally, the therapy enhanced renal function, suggesting that CAR-T therapy could provide new treatment avenues for patients with moderate to severe renal impairment.

The FUMANBA-1 Study is a Phase Ib/II, single-arm, multicenter study designed to evaluate the efficacy and safety of Equecabtagene Autoleucel in patients with R/R MM who had undergone three or more lines of previous treatment.

IASO Bio specializes in discovering and developing novel cell therapies and biologics for oncology and autoimmune diseases. The company's comprehensive capabilities span early discovery, clinical development, regulatory approval, and commercialization. IASO Bio's pipeline includes over 10 novel products, including Equecabtagene Autoleucel, which received Biologics License Application (BLA) approval from China's National Medical Products Administration (NMPA) in June 2023 and U.S. FDA IND approval for the treatment of R/RMM in December 2022. The company aims to provide transformative, curable, and affordable therapies to address unmet medical needs in China and globally.