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Study Shows Comparable Safety, Efficacy of Idecabtagene Vicleucel in Older Patients
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The therapy has similar benefits for both older and younger patients with multiple myeloma.
Idecabtagene vicleucel (Ide-cel, Abecma; Bristol Myers Squibb), a chimeric antigen receptor (CAR) T-cell therapy, demonstrated similar safety and efficacy amongst younger and older patients with multiple myeloma (MM). The findings, gathered from a multicenter retrospective study, show that geriatric characteristics such as comorbidities and organ dysfunction did not affect the efficacy of the treatment.
Lymphocyte life cycle concept | Image Credit: © Anastasiia - stock.adobe.com
MM is a common hematologic malignancy typically diagnosed in older adults with a median age of 69 years old. Advancements in treatments like immunotherapies and CAR T-cell therapy have greatly improved outcomes for patients with MM; however, these advances have largely been to the benefit of younger patients. Therefore, there is limited data on the clinical outcomes of older patients receiving CAR T-cell therapy, particularly in relation to comorbidities, frailty, performance status, and organ dysfunction. The retrospective analysis sought to assess the safety and efficacy of ide-cel alongside various geriatric factors experienced by older patients.1
Ide-cel was approved in 2021 by the FDA and is the first approved cell therapy indicated for adult patients with relapsed or refractory MM after 4 or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. The decision was based on positive results from the phase 2 KarMMa trial (NCT03361748), which showed ide-cel had overall response rates (ORR) of approximately70% and 85% overall response rates in younger and older patients, respectively.2,3
Ide-cel targets BCMA, a universally, highly expressed protein on the surface of malignant MM cells. As of 2024, there are 2 FDA approved BCMA-directed therapies: ide-cel and ciltacabtagene autoleucel (Carvykti; Janssen Biotech, Inc), which was approved in 2022.4,5
The researchers evaluated data from 5 center in the United States from patients who underwent leukapheresis followed by commercial ide-cel infusion by August 31, 2022, and after ide-cel infusion follow-up until November 2023. They evaluated 156 patients(aged <65 years, n = 81; and aged ≥65 years, n = 75) with a median follow-up of 14.2 months.1
At the 14.2-month follow-up, older patients (median age: 69 years; range, 65-83; 66.7% frail; 77.3% did not meet KarMMa eligibility criteria) had an ORR of 86.7%, as well as median progression-free survival and overall survival of 9.1 months and 26.5 months, respectively.1
Treatment-related adverse events included grade ≥3 cytokine-release syndrome and immune effector cell–associated neurotoxicity syndrome in 1% and 4% of older patients, respectively. According to the data, older patients had significantly higher prevalence of frailty, geriatric characteristics such as polypharmacy (≥5 drugs; 97%), ≥4 comorbidities (69%), and organ dysfunction (35%; P < .05) compared with younger patients.1
The findings offer more comprehensive data on the safety and efficacy of ide-cel in older patients, indicating that their treatment outcomes are comparable to younger patients. The study authors suggest that clinical trial criteria should be more inclusive of older patients with MM to optimize their treatment outcomes and identify those who could benefit the most from ide-cel.
