ASCO2021: CARTITUDE-1 Update on Ciltacabtagene Autoleucel for Resistant Myeloma
Posted: Friday, July 2, 2021
Responses to ciltacabtagene autoleucel (JNJ-68284528), a chimeric antigen receptor (CAR) T-cell therapy, deepened over time in nearly 100 patients with relapsed or refractory multiple myeloma, according to updated results from the phase Ib/II CARTITUDE-1 trial. Saad Zafar Usmani, MD, of Atrium Health’s Levine Cancer Institute in Charlotte, North Carolina, and colleagues presented the data, representing a median of 12.4 months follow-up, during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 8005).
Ciltacabtagene autoleucel has two B-cell maturation antigen–targeting single-domain antibodies, explained the team. A total of 97 patients who had received a median of six prior therapies—including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody—received a single infusion of ciltacabtagene autoleucel 5 to 7 days after lymphodepletion. The overall response rate per independent review committee, the study’s primary endpoint, was 97%, and 67% achieved a stringent complete response. The median duration of response was not reached, noted the authors, nor was median progression-free survival.
They are “early, deep, and durable responses,” highlighted Dr. Usmani and co-investigators, with median times to first response and to complete response or better of 1 month and 2 months, respectively. As such, “ciltacabtagene autoleucel is under further investigation in other multiple myeloma populations in earlier lines of therapy and in outpatient settings.”
Of 57 patients who were evaluable for minimal residual disease (MRD) assessment, 93% achieved MRD negativity. The 12-month progression-free survival and overall survival rates were 77% and 89%, respectively; four patients died of treatment-related adverse effects. Almost all patients (95%) experienced cytokine-release syndrome. However, it was grade 3 or higher in 4% of patients, and it resolved in all but one patient.
The target infusion dose was 0.75 × 106 CAR-positive viable T cells/kg. Beyond cytokine-release syndrome, grade 3 or 4 hematologic adverse effects occurring in 20% of patients or more included neutropenia (95%), anemia (68%), leukopenia (61%), thrombocytopenia (60%), and lymphopenia (50%).
Disclosure: The study authors’ disclosure information can be found at coi.asco.org.