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Cohort 2C of KarMMa-2: Idecabtagene Vicleucel for High-Risk Multiple Myeloma

By: Julia Fiederlein Cipriano
Posted: Friday, January 20, 2023

In the multicenter phase II KarMMa-2 trial, treatment with the B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor (CAR) T-cell therapy idecabtagene vicleucel resulted in frequent, deep, and durable responses in patients with triple-class–exposed relapsed and refractory multiple myeloma, according to Madhav Dhodapkar, MBBS, of Emory University, Atlanta, and colleagues. An analysis of cohort 2C, which was presented during the 2022 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 3314), yielded similar results in a population with inadequate responses to front-line autologous stem cell transplantation.

After undergoing lymphodepletion, 31 newly diagnosed patients received a single infusion of idecabtagene vicleucel at doses ranging from 150 to 450 Ă— 106 CAR-positive T cells. The complete response rate was 74.2%, and the overall response rate was 87.1%. The median duration of the time to response was 1 month. At 12 and 24 months, the duration of response rates were 100.0% and 92.1%; the progression-free survival rates were 90.1% and 83.1%; and the overall survival rates were 100.0% and 100.0%, respectively.

Grade 3 and 4 adverse events occurred in 93.5% of patients during or after infusion; neutropenia (80.6%), leukopenia (29.0%), and anemia (22.6%) were reported most frequently. Grade 1 and 2 cytokine-release syndrome was observed in 45.2% and 12.9% of patients, respectively. A total of 6.5% of patients had investigator-identified neurotoxicity.

Despite low tumor burden, cellular expansion was observed in the entire evaluable population. The level of cellular expansion was found to be higher in patients who achieved a complete response or better than in those who did not. Soluble BCMA was cleared 2 months after infusion in 77.4% of patients. Among the 23 evaluable patients who achieved a complete response or better, 16 demonstrated measurable residual disease (MRD) negativity 6 and 12 months after infusion; a total of 11 patients sustained MRD negativity at 24 months.

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


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