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Equecabtagene Autoleucel Shows Efficacy, Safety in Treatment of Patients With Heavily Pretreated Multiple Myeloma
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Key Takeaways
- Equecabtagene autoleucel shows high efficacy in RRMM, with a 96% overall response rate and 74.3% achieving complete response or better.
- The FUMANBA-1 trial reported a favorable safety profile, with manageable adverse events like cytokine release syndrome and neurotoxicity.
Patients with relapsed, refractory disease achieved deep, durable responses with equecabtagene autoleucel.
Equecabtagene autoleucel (Eque-cel, Fucaso; IASO Bio), a BCMA-targeting chimeric antigen receptor (CAR) T-cell therapy, demonstrated deep, durable responses and favorable safety in patients with heavily pretreated relapsed/refractory multiple myeloma (RRMM). The findings, published in JAMA Oncology, are from the single-arm, open-label, phase 1b/2 FUMANBA-1 trial (ChiCTR2000033946).1,2
MM is an incurable, heterogeneous blood cancer that is characterized by periods of remission followed by relapse. According to the Leukemia & Lymphoma Society, almost all patients with MM will become refractory to treatment or relapse, underscoring the need for more therapeutic options as the disease progresses. CAR T-cell therapy has gained significant clinical attention, leading to multiple clinical trials that resulted in FDA approvals. Real-world analyses support the clinical trial findings, further supporting the efficacy of this therapeutic option for patients with dwindling treatment alternatives.3
CAR T-cells targeting cancer cells | Image Credit: © furyon - stock.adobe.com
Eque-cel is a BCMA-targeting CAR T-cell therapy that received approval for treatment of patients with RRMM by China’s National Medical Products Administration in June of 2023. In April of 2024, the FDA accepted the manufacturer’s investigational new drug application (IND) for treatment of patients with non-renal systemic lupus erythematosus and lupus nephritis, allowing for the initiation of clinical trials in the United States.4,5
The FUMANBA-1 trial enrolled a total of 116 patients who underwent apheresis, of which 105 patients proceeded to lymphodepleting chemotherapy, and 103 patients received an eque-cel infusion. Approximately 80% of patients had stage 2 or 3 disease and 38.6% had high-risk cytogenetics. All patients underwent 4 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent, and 11.7% received CAR T-cell therapy.2,6
At a median 13.8 month follow up (0.4-27.2), 96% of patients achieved an overall response rate, with 74.3% achieving a complete response or better. The median progression-free survival was not reached, and the 12-month progression-free survival rate was 78.8% (95% CI, 68.6–86.0). Minimal residual disease negativity, at a sensitivity threshold of 10−5, was achieved by 95.0% of patients.2,6
The reported adverse events (AEs) were manageable, of which the most common were grade 1 or 2 cytokine release syndrome (CRS; 92.3%) and grade 1 or 2 immune effector cell-associated neurotoxicity syndrome (1.9%). All cases of neurotoxicity and CRS were resolved following treatment.2,6
These results underscore the potential of equecabtagene autoleucel as a transformative therapeutic option for patients with relapsed or refractory multiple myeloma, particularly those who have exhausted standard treatments. The high overall response rate, durable progression-free survival, and favorable safety profile highlight its promise in addressing critical unmet needs in this patient population. As CAR T-cell therapies continue to evolve, eque-cel represents a significant step forward in the quest to improve outcomes for patients with RRMM and high-risk disease.
