|The following article features coverage from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Click here to read more of Hematology Advisor‘s conference coverage.|
Ciltacabtagene autoleucel (cilta-cel), a B cell maturation antigen (BCMA)-targeting therapy, appears to show promising activity among patients with previously treated multiple myeloma (MM), according to research presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
Cilta-cel, a chimeric antigen receptor (CAR) T-cell therapy, expresses 2 BCMA-directed antibodies. For the phase 2 CARTITUDE-2 study (ClinicalTrials.gov Identifier: NCT04133636), researchers are evaluating the safety and efficacy of cilta-cel in several cohorts of patients with MM.
In this poster, researchers presented data from Cohort A of CARTITUDE-2, which included patients with progressive MM after 1 to 3 prior lines of therapy. No patients had received previous exposure to any BCMA-targeting therapy. Patients received a single cilta-cel infusion.
A total of 20 patients were included. Data were cut off in February 2021, at which point the median follow-up was 5.8 months (range, 2.5-9.8). The median patient age was 60 years (range, 38-75), 65% of patients were male, and 8 had undergone 3 prior lines of therapy. Almost all patients (95%) were refractory to their last line of therapy, and 40% of patients were triple refractory.
The overall response rate was 95%, with 75% of patients reaching a stringent complete response, and 85% of patients reaching a very good response or better. The median time to response was 1 month and the median duration of response was not reached. All 4 patients evaluable for minimal residual disease were negative per study protocol.
Grade 3 or worse hematologic adverse events included neutropenia (90%), thrombocytopenia (35%), anemia (40%), lymphopenia (60%), and leukopenia (55%). Cytokine release syndrome was observed in 85% of patients; 10% of these were grade 3 or 4.
“A safety profile in this patient population was manageable, including into 1 patient that was treated in an outpatient setting,” the study’s presenter said. “Cilta-cel is being evaluated in other cohorts of CARTITUDE-2, in earlier line settings and in a phase 3, CARTITUDE-4 study in patients with 1 to 3 prior lines of therapy.”
Disclosure: Some [or one] study author(s) declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
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Agha ME, Cohen AD, Madduri D, et al. CARTITUDE-2: Efficacy and safety of ciltacabtagene autoleucel (cilta-cel), a BCMA-directed CAR T-cell therapy, in patients with progressive multiple myeloma (MM) after one to three prior lines of therapy. J Clin Oncol. 2021;39:(suppl 15; abstr 8013). doi:10.1200/JCO.2021.39.15_suppl.8013