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Shaji K. Kumar, MD
Prashant Kapoor, MD, FACP
Shaji K. Kumar, MD
Prashant Kapoor, MD, FACP
Posted: Wednesday, June 8, 2022
Patients with relapsed or refractory multiple myeloma treated with a single infusion of ciltacabtagene autoleucel had deep and durable responses after 2 years, according to Saad Zafar Usmani, MD, MBA, of Memorial Sloan Kettering Cancer Center, New York, and colleagues. Ciltacabtagene autoleucel is a chimeric antigen receptor (CAR) T-cell therapy with two single-domain antibodies that target B-cell maturation antigens (BCMAs). This update from the CARTITUDE-1 trial was presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 8028).
This phase Ib/II trial enrolled 97 patients with multiple myeloma who had received either three or more prior lines of therapy or were refractory to a proteasome inhibitor or an immunomodulatory drug. This cohort had been exposed to a median of six prior lines of therapy, and 84% of patients had been exposed to five drugs before enrollment. Patients underwent lymphodepletion, then received a single infusion of ciltacabtagene autoleucel at a target dose of 0.75 x 106 CAR-positive viable T cells/kg.
At 21.7 months of follow-up, the overall response rate was 97.9%, with 94.9% of patients achieving a very good partial response and 82.5% achieving a stringent complete response. This is an improvement from the 1-year follow-up, at which the overall response rate was 97% and the stringent complete response rate was 67%. There were 61 patients evaluable for measurable residual disease (MRD), and 92% of these patients achieved MRD negativity; it was sustained for 6 months or more in 44% of patients and for more than 12 months in 18%. The 2-year progression-free survival rate in patients with sustained MRD activity for 6 months was 91% and 100% in those who sustained MRD negativity for 12 months.
Since the 1-year follow-up, there were no new safety signals or events related to CAR T-cell therapy. However, there were 15 second primary malignancies reported in 11 patients over the 2-year follow-up.
Disclosures: For a full list of authors’ disclosures, visit coi.asco.org.
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