Cohort A of the CARTITUDE-2 study is evaluating cilta-cel safety and efficacy in patients with multiple myeloma who received 1 to 3 prior lines of therapy.
In patients with progressive multiple myeloma after 1 to 3 prior lines of therapy, a single ciltacabtagene autoleucel (cilta-cel)infusion led to deepening and durable responses at 17.1 months follow-up in this difficult-to-treat population with a poor prognosis. This is according to the updated clinical data from Cohort A of the ongoing multicohort phase 2 CARTITUDE-2 study (NCT04133636).1
The data were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, which is taking place from June 3-7, 2022 in Chicago, by Hermann Einsele, MD, of Universitätsklinikum Würzburg in Germany.
In February, cilta-cel (CARVYKTI, Jansen Biotech, Legend Biotech), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy, received FDA approval for the treatment of adults with relapsed or refractory multiple myeloma after 4 or more prior lines of therapy.2
CARTITUDE-2 is evaluating the safety and efficacy of cilta-cel in various multiple myeloma settings including earlier lines. Cohort A of the study is evaluating cilta-cel safety and efficacy in patients with multiple myeloma who received 1 to 3 prior lines of therapy, including a proteasome inhibitor and immunomodulatory agent, and who are lenalidomide-refractory and have had no prior exposure to BCMA-targeting agents.
As of January 2022 (median follow-up 17.1 months), 20 patients (65% male, median age 60) received a single cilta-cel infusion (target dose 0.75×106 CAR+ viable T cells/kg)
post lymphodepletion. Safety and efficacy were assessed, and the primary end point was minimal residual disease (MRD) negativity at 10-5.
The overall response rate (ORR) was 95%, while 90% achieved a complete response
(CR) or better, and 95% had a very good partial response (VGPR) or better. The median times to first and best response were 1 month and 2.6 months, respectively. Of the patients, 16 were MRD-evaluable, all of whom achieved MRD negativity at 10-5. The median duration of response (DOR) was not reached and the 12-month event-free rate was 79%. The 12-month progression free survival (PFS) rate was 75%.
Meanwhile, the median time to onset of cytokine release syndrome was 7 days and it occurred in 95% of patients, with median duration of 3 days. The rates of neurotoxicity and immune effector cell-associated neurotoxicity syndrome (ICANS) were 30% and 15%, respectively, while 1 patient had grade 2 facial paralysis.
One death occurred due to COVID-19, while 2 were due to progressive disease, and 1 was due to sepsis that was unrelated to the treatment.
The updated data from the CARTITUDE-2 study “demonstrates the promise of cilta-cel in earlier lines of treatment,” said Ying Huang, PhD, chief executive officer of Legend Biotech.3
This patient population is being further evaluated in the CARTITUDE-4 study (NCT04181827).
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