18-Month Follow-up on Ciltacabtagene Autoleucel in Patients With Multiple Myeloma

By: Julia Fiederlein Cipriano
Posted: Tuesday, February 21, 2023

Niels W.C.J. Van De Donk, MD, PhD, of Amsterdam University Medical Center, and colleagues conducted a study to investigate the B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell therapy ciltacabtagene autoleucel in patients with multiple myeloma who relapsed within a year of treatment with an upfront standard-of-care regimen. The 18-month follow-up data from cohort B of the phase II CARTITUDE-2 trial, which were presented during the 2022 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 3354), represent a potentially significant advancement in a population with a high unmet need.

“Results at this longer follow-up show durability and deepening of response…and maintenance of [the] progression-free survival rate,” the investigators remarked.

After undergoing lymphodepletion, 19 patients who received one prior line of therapy and experienced progressive disease were administered a single ciltacabtagene autoleucel infusion; of this population, 79% underwent prior autologous stem cell transplantation. The investigators reported an overall response rate of 100%, including 100% with a very good partial response or better and 90% with a complete response or better. The median times to first and best response were 1.0 and 5.1 months, respectively. Of the 15 measurable residual disease (MRD)-evaluable patients, 14 achieved MRD negativity at a threshold of 10^-5 cells. The median duration of response was not reached. The 12-month progression-free survival and event-free rates were 90% and 84%, respectively.

The most common treatment-emergent adverse events were hematologic in nature (grade 3 or 4: neutropenia, 90%; lymphopenia, 42%; thrombocytopenia, 26%; leukopenia, 26%). The median time from infusion to the onset of cytokine-release syndrome was 8 days, and it was reported in 84% of patients; all cases were resolved. The levels of interleukin (IL)-6, interferon gamma, IL-2 receptor α, and IL-10 were found to increase after infusion, peak from days 7 to 14, and return to baseline levels within 2 to 3 months.

Disclosure: For full disclosures of the study authors, visit ash.confex.com.

2022 ASH Annual Meeting and Exposition

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