Dr Munshi on the Background of the CARTITUDE-1 Trial in Multiple 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 background of the phase 1b/2 CARTITUDE-1 trial (NCT03548207) of ciltacabtagene autoleucel (cilta-cel; Carvykti) in patients with relapsed/refractory multiple myeloma and highlights the specific patient population enrolled in the study.

At the 2023 EHA Congress, Munshi and colleagues presented long-term findings from the phase 1b/2 trial, which demonstrated sustained efficacy and safety for the CAR T-cell therapy. 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 prior data from CARTITUDE-1.

The phase 1b/2 study focused including patients with relapsed/refractory myeloma who were previously exposed to proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, Munshi begins. This created an advanced, heavily pretreated patient population. Those enrolled proceeded to undergo apheresis, followed by lymphodepletion and the infusion of cilta-cel, Munshi begins. Bridging therapy was also permitted during the manufacturing of the CAR T-cell product.

Patients received a median of 6 prior lines of treatment, and the median time from diagnosis was 5.9 years. Additionally, 87.6% of patients were triple-class refractory, 42.3% were penta-drug refractory, and 99% were refractory to their last treatment.Despite this heavily pretreated patient population, there overall response rate was 97.9% with long-term follow-up, which was consistent with prior findings. Furthermore, the median progression-free survival (PFS) was 34.9 months, and the median overall survival (OS) was not reached. With prior standard therapies in this setting, patients with these characteristics would only have a fraction of that PFS expectancy and an expected survival of approximately 1 year, Munshi concludes.