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CARTITUDE-2 Cohort A Shows Deep and Durable Responses with Cilta-Cel in Patients with Lenalidomide-Refractory MM

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Ciltacabtagene autoleucel (cilta-cel) is a chimeric antigen receptor T-cell therapy that expresses 2 B-cell maturation antigen (BCMA)-targeting, single-domain antibodies. Cilta-cel is being evaluated in CARTITUDE-2, a phase 2 study evaluating the safety and efficacy of cilta-cel in patients with multiple myeloma (MM) in various patient populations. Specifically, cohort A aimed to determine the safety and efficacy of cilta-cel in patients with MM who received 1 to 3 prior lines of therapy and were refractory to lenalidomide, a population historically known to have a poor prognosis.

A total of 20 patients received cilta-cel and were followed for a median of 17.1 months. Patients included in the cohort had progression after 1 to 3 prior lines of therapy, including an immunomodulatory drug and proteosome inhibitor; were refractory to lenalidomide; and had no prior exposure to a BCMA-targeting agent.

The primary end point was minimal residual disease (MRD) negativity at 10-5. Patients received a median of 2 prior lines of therapy; 95% were refractory to the last line of therapy; and 40% were triple class refractory. The overall response rate was 95%: 90% of patients achieved complete response or better and 95% of patients have a very good partial response or better. The median time to first response was 1.0 month, and the median time to best response was 2.6 months. Of the 20 patients in the cohort, 16 were evaluated for MRD negativity, all of whom achieved MRD negativity at 10-5. The 12-month progression-free survival rate was 75%.

In terms of safety, cytokine release syndrome (CRS) occurred in 95% of patients, 10% of which were grade 3/4. The median time to onset of CRS was 7 days, and the median duration was 3 days. A total of 30% of patients experienced neurotoxicity, 15% had immune effector cell–associated neurotoxicity syndrome, and 1 patient had grade 2 facial paralysis. Overall, 4 deaths occurred, 1 due to COVID-19, 2 due to progressive disease, and 1 due to sepsis unrelated to treatment.

Follow-up is still ongoing, but overall, 1 infusion of cilta-cel led to deep and durable responses in lenalidomide-refractory patients after 1 to 3 prior lines of therapy. This population is currently being investigated in CARTITUDE-4, which has concluded enrollment.

Source

Cohen A, Einsele H, Delforge M, et al. Updated clinical data and biological correlative analyses of ciltacabtagene autoleucel (cilta-cel) in lenalidomide-refractory multiple myeloma after 1–3 prior lines of therapy: CARTITUDE-2 cohort A. Oral abstract presented at: International Myeloma Foundation; August 25-27, 2022; Los Angeles, CA.

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