Dr Usmani on the FDA Approval of Cilta-Cel for Relapsed/Refractory Multiple Myeloma

Saad Z. Usmani, MD, MBA, FACP, FASCO, chief, Myeloma Service, Memorial Sloan Kettering Cancer Center, discusses the significance of the FDA approval of ciltacabtagene autoleucel (cilta-cel; Carvykti) for patients with relapsed/refractory multiple myeloma who have received at least 1 prior line of therapy.

On April 5, 2024, the FDA approved cilta-cel for the treatment of adult patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and who are refractory to lenalidomide (Revlimid). This regulatory decision was based on findings from the phase 3 CARTITUDE-4 trial (NCT04181827). Data from the press release says that cilta-cel resulted in a 59% reduction in the risk of disease progression or death vs standard therapies, according to the press release issued by Johnson & Johnson.

Although the indication expansion for cilta-cel permits the use of this agent in more patients than ever before, Usmani says that the accessibility of CAR T-cell therapy and the capacity of cellular therapy transplant centers remain areas of necessary further consideration. Triplet therapy regimens are available to patients with multiple myeloma in the early relapsed setting, Usmani notes. However, for functionally high-risk patients who did not experience long-term progression-free survival outcomes with their first or second line of therapy, cilta-cel is a promising subsequent treatment option, Usmani explains. The efficacy of cilta-cel in the early relapsed setting of multiple myeloma was initially demonstrated in small cohorts of patients in the phase 2 CARTITUDE-2 trial (NCT04133636), and data in this patient population from the larger phase 3 CARTITUDE-4 trial validated the CARTITUDE-2 findings, according to Usmani.

Conducting informative conversations with patients regarding their treatment options in the early relapsed setting is important, Usmani emphasizes. Additionally, patients who receive cilta-cel will experience the benefit of a drug-free period after recovering from this CAR T-cell therapy infusion, Usmani says. When discussing myeloma treatment options with patients, oncologists should present the benefits of cilta-cel along with the potential logistical complications of receiving such a therapy, Usmani concludes.