Idecabtagene Vicleucel Under Study in Relapsed and Refractory Multiple Myeloma
Posted: Friday, March 12, 2021
Treatment with idecabtagene vicleucel appears to induce “frequent and deep” responses in patients with triple-class–exposed relapsed and refractory myeloma, according to the results of a pivotal phase II study published in The New England Journal of Medicine. Roughly one-quarter of patients treated with the B-cell maturation antigen–directed chimeric antigen receptor (CAR) T-cell therapy achieved minimal residual disease–negative status.
“The results of this trial represent a true turning point in the treatment of this disease. In my 30 years of treating myeloma, I have not seen any other therapy as effective in this group of patients,” stated initial study author Nikhil C. Munshi, MD, of Dana-Farber Cancer Institute, Boston, in an institutional press release.
The KarMMa trial included 140 patients with disease after at least 3 previous regimens, including a proteasome inhibitor, an immunomodulating agent, and an anti-CD38 antibody. In all, 128 patients received idecabtagene vicleucel at target doses ranging from 150 × 106 to 450 × 106 CAR-positive T cells.
At a median follow-up of 13.3 months, 94 patients (73%) had a response, and 42 (33%) had a complete response or better. Minimal residual disease–negative status (<10−5 nucleated cells) was confirmed in 33 patients; this translated to 26% of all 128 patients who were treated and 79% of the 42 patients who had a complete response or better.
Common toxic effects associated with this immunotherapy included neutropenia in 117 patients (91%), anemia in 89 (70%), and thrombocytopenia in 81 (63%). Cytokine-release syndrome was reported in 107 patients (84%), including 7 (5%) who had events of grade 3 or higher. Almost all patients experienced grade 3 or 4 toxic events.
Disclosure: For full disclosures of the study authors, visit www.nejm.org.