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Ide-cel in Relapsed/Refractory Multiple Myeloma

Compared with standard regimens, a chimeric antigen receptor (CAR) T-cell therapy that targets the B-cell maturation antigen (BCMA) improved progression-free survival and complete responses in patients with triple-class–exposed relapsed and refractory multiple myeloma, a study shows. The toxicity of the therapy, idecabtagene vicleucel (ide-cel, also called bb2121), was consistent with earlier studies.

Participants in the international, open-label, phase 3 trial were adults who had previously received immunomodulatory agents, proteasome inhibitors, or daratumumab and had disease refractory to the last regimen. Ide-cel 150×106 to 450×106 CAR-positive T cells or 1 of 5 standard regimens produced these outcomes based on a primary endpoint of progression-free survival: “A total of 386 patients underwent randomization: 254 to ide-cel and 132 to a standard regimen. A total of 66% of the patients had triple-class–refractory disease, and 95% had daratumumab-refractory disease. At a median follow-up of 18.6 months, the median progression-free survival was 13.3 months in the ide-cel group, as compared with 4.4 months in the standard-regimen group (hazard ratio for disease progression or death, 0.49; 95% confidence interval, 0.38 to 0.65; P <0.001). A response occurred in 71% of the patients in the ide-cel group and in 42% of those in the standard-regimen group (P <0.001); a complete response occurred in 39% and 5%, respectively. Data on overall survival were immature. Adverse events of grade 3 or 4 occurred in 93% of the patients in the ide-cel group and in 75% of those in the standard-regimen group. Among the 225 patients who received ide-cel, cytokine release syndrome occurred in 88%, with 5% having an event of grade 3 or higher, and investigator-identified neurotoxic effects occurred in 15%, with 3% having an event of grade 3 or higher.”

Source: New England Journal of Medicine