Dr Patel on the FDA Approval of Ide-Cel for Triple Class–Exposed R/R Multiple Myeloma

Krina K. Patel, MD, MSc, associate professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the significance of the FDA approval of idecabtagene vicleucel (ide-cel; Abecma) for patients with triple class–exposed relapsed/refractory multiple myeloma.

On April 4, 2024, the FDA approved ide-cel for adult patients with relapsed/refractory multiple myeloma who have received 2 or more prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. This regulatory decision was supported by findings from the phase 3 KarMMa-3 trial (NCT03651128), in which treatment with ide-cel led to a 51% reduction in the risk of disease progression or death compared with standard therapy in this patient population (HR, 0.49; 95% CI, 0.38-0.64; P < .0001).

The definition of relapsed/refractory multiple myeloma is constantly evolving with the addition of new therapies to the treatment armamentarium as oncologists aim to deliver the most effective treatment strategies to patients earlier in the disease course, Patel says. For instance, quadruplet regimens are now used in the upfront setting, which has shifted the roles of novel agents, such as CAR T-cell therapies and bispecific antibodies, Patel explains. Clinical trials such as KarMMa-3 have demonstrated that patients receiving the best available therapies in earlier treatment lines are typically not as refractory as those receiving them in later lines of therapy, and therefore may experience superior treatment outcomes, Patel notes. However, patients typically develop triple class–exposed disease by the third-line setting because of the use of anti-CD38 antibodies, PIs, and IMiDs in earlier lines of therapy. This means that it is possible for patients to display relapsed/refractory disease in earlier lines of therapy, Patel emphasizes.

The FDA approval of ide-cel in triple class–exposed disease is significant because it provides a novel treatment option for patients who would otherwise have a limited number of effective subsequent treatment options, according to Patel. Continued expansion of the multiple myeloma treatment arsenal has both benefits and drawbacks, and it is important to continue to develop therapies that patients are eligible to receive when they would derive the most benefit, Patel concludes.