JAMA Oncology Publishes Phase 1b/2 Study on IASO Bio's Equecabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma

Results from the phase 1b/2 clinical study FUMANBA-1 of Equecabtagene Autoleucel, a fully human anti-BCMA CAR-T therapy developed by IASO Biotherapeutics, have been published in JAMA Oncology. This study examined the treatment's efficacy and safety in patients with relapsed/refractory multiple myeloma (R/RMM) who had undergone at least three prior lines of therapy. Equecabtagene Autoleucel, also known as Fucaso™, showed promising results, achieving high response rates and lasting remissions with a favorable safety profile.

The study included data from 103 patients who received the CAR-T therapy as of September 2022, with a median follow-up period of 13.8 months. Analyzing 101 evaluable patients, researchers found a remarkable overall response rate (ORR) of 96%, with a stringent complete response/complete response (sCR/CR) rate of 74.3%. For those without previous CAR-T therapy, the ORR was even higher at 98.9%, and the sCR/CR rate was 78.7%. The median time to response was 16 days, but the median duration of response and progression-free survival (PFS) had not yet been determined. The 12-month PFS rate stood at 78.8%, and 95% of the patients reached minimal residual disease (MRD) negativity, signifying profound treatment effectiveness.

In terms of safety, the study noted that 93.2% of patients experienced cytokine release syndrome (CRS), primarily grades 1 or 2, with only one instance of grade 3 or higher CRS. Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in just two patients, and both cases were mild (grade 1 and grade 2).

Updated data presented at the 2023 American Society of Hematology (ASH) Annual Meeting indicated an ORR of 96.1% among 103 patients with a longer median follow-up of 18.07 months. The sCR/CR rate improved to 77.7%, and all patients with sCR/CR achieved 100% MRD negativity. Notably, among those without prior CAR-T therapy, the ORR was 98.9%, with an sCR/CR rate of 82.4%, and 97.8% reached MRD negativity.

The FUMANBA-1 study's findings highlight the encouraging potential of Equecabtagene Autoleucel in treating R/RMM. The therapy's fully human design addresses common immunogenicity problems associated with animal-derived CAR-T cells, while optimizing affinity for BCMA-expressing tumor cells. This allows for rapid expansion and long-term persistence in the body.

Experts from leading Chinese medical institutions praised the therapy's impact, noting significant survival benefits for patients over the past year since its approval in China in June 2023. They emphasized the therapy’s novel design, which maintains optimal affinity and dissociation kinetics, leading to sustained remissions.

Dr. Jie Chen, Chief Medical Officer of IASO Bio, expressed satisfaction with the study results. He acknowledged the dedication of the FUMANBA-1 research team and highlighted the ongoing phase III clinical study (FUMANBA-3) aimed at treating multiple myeloma patients with one to two prior therapies. Dr. Chen anticipates that this study will yield positive outcomes and provide new treatment options.

The FUMANBA-1 study involved multiple centers across China and enrolled patients who had undergone at least three prior lines of therapy, including proteasome inhibitors and immunomodulatory agents. Patients with previous BCMA CAR-T therapy were also eligible.

Equecabtagene Autoleucel employs lentivirus as a gene vector to modify autologous T cells. The CAR construct contains a fully human scFv, CD8a hinge and transmembrane, and signaling domains for co-stimulation and activation. This innovative therapy demonstrates rapid and potent efficacy with long-term in vivo persistence, offering significant potential for patients with multiple myeloma.

IASO Biotherapeutics, a leading biopharmaceutical company, focuses on innovative cell therapies and biologics for oncology and autoimmune diseases. With a robust pipeline and comprehensive development capabilities, IASO aims to deliver transformative treatments to patients worldwide.