Site Editors
Shaji K. Kumar, MD
Prashant Kapoor, MD, FACP
Shaji K. Kumar, MD
Prashant Kapoor, MD, FACP
Posted: Wednesday, October 12, 2022
The updated clinical data from cohort B of the phase II CARTITUDE-2 study were presented by Mounzer Agha, MD, of the University of Duhok, Iraq, and colleagues during the 2022 Society of Hematologic Oncology (SOHO) Annual Meeting (Abstract MM-153). The results of this trial, which assessed the B-cell maturation antigen (BCMA)-directed, chimeric antigen receptor (CAR) T-cell therapy ciltacabtagene autoleucel in patients with multiple myeloma, determined that this agent is effective in those with advanced disease.
“A single ciltacabtagene autoleucel infusion resulted in deep and durable responses and manageable safety in functionally high-risk patients with multiple myeloma and early clinical relapse/treatment failure to initial therapy,” concluded the investigators.
Cohort B contained 19 patients with multiple myeloma who received one prior line of therapy and experienced progressive disease; individuals did not undergo previous treatment with CAR-T/anti-BCMA therapies. Participants were administered a single infusion of ciltacabtagene autoleucel after lymphodepletion.
The median follow-up was 13.4 months. A total of 79% of individuals underwent prior autologous stem cell transplantation. The objective response rate was 100%, with a complete response rate of 90% and a very good partial response rate—defined as a 90% decrease in the serum monoclonal component level—of 95%. Although the median duration of response was not reached, the median times to first and best response were 0.95 and 5.1 months, respectively.
Of 15 patients who were evaluable for measurable residual disease (MRD), 14 achieved the primary endpoint of MRD 10-5 negativity. The progression-free survival rate was 90%, and the event-free rate was 88.9%. Cytokine-release syndrome was observed in all patients, but it eventually resolved. Immune effector cell–associated neurotoxicity syndrome was detected in one patient, and one death occurred after treatment because of progressive disease.
Disclosure: Disclosure information was not provided.
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