Initial Results From Cohort A of CARTITUDE-2: Ciltacabtagene Autoleucel for Progressive Myeloma
Posted: Wednesday, August 18, 2021
Mounzer E. Agha, MD, of UPMC Hillman Cancer Center, Pittsburgh, and colleagues presented initial results from Cohort A of the phase II CARTITUDE-2 study during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 8013). This trial evaluated the safety and efficacy of the chimeric antigen receptor (CAR) T-cell therapy ciltacabtagene autoleucel in patients with progressive multiple myeloma after prior therapy. They found that a single infusion induced early and deep responses, with manageable safety in this outpatient setting.
This study enrolled 20 patients with progressive multiple myeloma who received one to three prior lines of therapy into Cohort A. Participants were required to be lenalidomide-refractory, with no prior exposure to B-cell maturation antigen–targeting agents. A single ciltacabtagene autoleucel dose of 0.75 x 106 CAR-positive viable T cells/kg was administered 5 to 7 days after initiating lymphodepletion and fludarabine.
The median patient age was 60, with a median follow-up of 5.8 months; 95% of patients were refractory to their last therapy. All patients had been exposed to immunomodulatory drugs, proteasome inhibitors, and dexamethasone. With a median time to first response of 1 month and a median time to best response of 1.9 months, the overall response rate was 95%; 75% of individuals achieved a stringent complete response or complete remission, and 85% reached at least a very good partial response.
Hematologic adverse events such as neutropenia, lymphopenia, leukopenia, anemia, and thrombocytopenia affected at least 20% of patients. Cytokine-release syndrome was observed in 85% of participants, with 10% being grade 3 or 4; the median time to onset was 7 days, with a median duration of 3.5 days. CAR T-cell neurotoxicity was observed in 20% of individuals, and three patients experienced immune effector cell–associated neurotoxicity syndrome.
Disclosure: Dr. Agha reported no conflicts of interest. For full disclosures of the other study authors, visit coi.asco.org.
