Dr Usmani on the Optimal Role for Cilta-Cel in Relapsed/Refractory Multiple Myeloma

Saad Z. Usmani, MD, MBA, FACP, FASCO, chief, Myeloma Service, Memorial Sloan Kettering Cancer Center, discusses the optimal role for ciltacabtagene autoleucel (cilta-cel; Carvykti) in patients with relapsed/refractory multiple myeloma, as well as key factors influencing the selection of this CAR T-cell therapy over other treatment regimens.

On April 5, 2024, the FDA approved cilta-cel for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and who are refractory to lenalidomide (Revlimid), Usmani begins. Findings from the phase 3 CARTITUDE-4 trial (NCT04181827) supported this regulatory decision, demonstrating a 59% reduction in the risk of disease progression or death in patients treated with the CAR T-cell therapy (n = 208) vs standard-of-care regimens (n = 211).

Cilta-cel is a viable treatment option for patients with functional, high-risk disease who are refractory to lenalidomide, Usmani emphasizes. He notes that the agent may have particular benefit for patients who experience early relapse within the first 2 years of their myeloma diagnosis. This group typically includes patients with documented high-risk disease in addition to patients with standard-risk myeloma who may have had high-risk clones sitting outside of the pelvic bone that were not identified as part of their early diagnostic workup, Usmani expands. If the clone cells survive, they may undergo proliferation and eventually lead to disease relapse, he explains.

When considering the use of cilta-cel, determining factors include a patient’s risk of infection, their disease biology, and the pace of the disease course, Usmani continues. A patient’s preference for undergoing continuous therapy with a triplet regimen compared with receiving a one-time infusion of cilta-cel should also be considered during treatment decision-making, Usmani concludes. With cilta-cel, patients with relapsed/refractory multiple myeloma may experience a treatment-free period as early as their first relapse, which could reduce the burdens associated with continuous treatment.