Site Editors
Shaji K. Kumar, MD
Prashant Kapoor, MD, FACP
Shaji K. Kumar, MD
Prashant Kapoor, MD, FACP
Posted: Monday, June 20, 2022
The CARTITUDE-2 study, performed by Hermann Einsele, MD, of Universitätsklinikum Würzburg, Germany, and colleagues evaluated the B-cell maturation antigen (BCMA)-directed, chimeric antigen receptor (CAR) T-cell therapy ciltacabtagene autoleucel in patients with lenalidomide-refractory multiple myeloma. During the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 8020), the investigators presented their updated efficacy and safety results in this previously treated population.
“At a longer median follow-up of 17.1 months, a single ciltacabtagene autoleucel infusion led to deepening and durable responses in [these] patients,” concluded the study authors. “Follow-up is ongoing. This patient population is being further evaluated in the CARTITUDE-4 study (ClinicalTrials.gov identifier NCT04181827), which has concluded enrollment.”
The study enrolled 20 patients with multiple myeloma who experienced disease progression after one to three prior lines of therapy and were refractory to lenalidomide. Participants were required to have no prior exposure to BCMA-targeting therapies and were administered a single dose of ciltacabtagene autoleucel after lymphodepletion.
With a median of 3.5 years since the diagnosis of multiple myeloma, 95% of patients were refractory to their most recent therapy line, and 40% were triple-class–refractory. The objective response rate was 95%, and 90% of individuals achieved a complete response or better. All 16 measurable residual disease (MRD)-evaluable participants attained MRD negativity. Of note, the 12-month progression-free survival rate was 75%, and the event-free survival rate was 79%.
Cytokine-release syndrome, which was reported in 95% of participants, had a median time to onset of 7 days; the median duration was 3 days. Neurotoxicity, immune effector cell–associated neurotoxicity syndrome, and facial paralysis occurred in six, three, and one patient, respectively. The expansion of CAR T cells appeared to peak at around 10.5 days, with a median persistence of 153.5 days.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
JNCCN Spotlights
