Dr Munshi on Implications of Findings From the CARTITUDE-1 Trial of Cilta-Cel in Myeloma

Nikhil C. Munshi, MD, director of the Basic and Correlative Science at Jerome Lipper Multiple Myeloma Center; Kraft Family Chair, director of Multiple Myeloma Immune Effector Cell Therapy, senior physician at Dana-Farber Cancer Institute, and a professor of Medicine at Harvard Medical School, discusses the implications of the findings from the phase 1b/2 CARTITUDE-1 trial (NCT03548207) of ciltacabtagene autoleucel (cilta-cel; Carvykti) in patients with relapsed/refractory multiple myeloma and the CAR T-cell therapy’s subsequent FDA approval for use in this patient population.

In February 2022, the FDA approved cilta-cel for the treatment of adult patients with relapsed/refractory multiple myeloma following 4 or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, based on data from CARTITUDE-1.

Updated findings from the trial were presented at the 2023 EHA Congress, which demonstrated sustained efficacy and safety data for the CAR T-cell therapy with long-term follow-up. The overall response rate (ORR) for patients treated during the trial remained consistent in the updated findings, Munshi says. In the data that supported the FDA approval, the ORR was 98%, and in the final data analysis, the ORR was 97.9%. In the prior analysis, the median progression-free survival (PFS) had not yet been reached; in the final analysis the median PFS-was 34.9 months (95% CI, 25.2–not evaluable).

Based on the data from CARTITUDE-1, this patient population should have access to cilta-cel, and it has become an important treatment option for patients with relapsed/refractory multiple myeloma, Munshi explains. For some patients, cilta-cel has shown improved outcomes for patients after other treatments have stopped working, and the CAR T-cell therapy has delivered promising and durable responses, he concludes.