Dr Dhakal on Survival and Safety Outcomes With Cilta-Cel in R/R Myeloma

Binod Dhakal, MD, associate professor, Division of Hematology and Oncology, Medical College of Wisconsin, discusses survival and safety data from the phase 3 CARTITUDE-4 study (NCT04181827) evaluating ciltacabtagene autoleucel (Carvykti; cilta-cel) in patients with relapsed/refractory multiple myeloma.

CARTITUDE-4 is a randomized trial evaluating the efficacy of cilta-cel vs standard of care (SOC) treatment in patients with multiple myeloma who have received 1 to 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or are refractory to lenalidomide (Revlimid). SOC regimens included either daratumumab, pomalidomide, and dexamethasone (DPd) or pomalidomide, bortezomib, and dexamethasone (PVd). Previously reported data from the initial analysis demonstrated a significant progression-free survival (PFS) benefit for cilta-cel, with a hazard ratio (HR) of 0.26 at a median follow-up of 15.9 months. On April 5, 2024, the FDA approved cilta-cel for this population based on data from CARTITUDE-4.

Notably, updated survival results were presented at the 21st IMS Annual Meeting. At a median follow-up of 33.6 months, (range, 0.1-45.0), the 30-month overall survival (OS) rate with cilta-cel was 76.4% vs 63.8% with SOC (HR, 0.55; 95% CI, 0.39-0.79; P = .0009), Dhakal reports. This translated to a 45% reduction in the risk of death. The 30-month OS rates were 76% with cilta-cel and 64% with the SOC.

In terms of progression-free survival (PFS), the 30-month PFS rate was 59.4% and 25.7% with cilta-cel vs the SOC, respectively. This translated to a 71% reduction in the risk of disease progression or death (HR, 0.29; 95% CI, 0.22-0.39; P <.0001). Although the median PFS and OS were not reached in either treatment arm, OS and PFS benefit with cilta-cel vs SOC was observed across all prespecified patient subgroups, Dhakal notes.

The regimen's safety profile was consistent with previous interim analyses, he continues. There were 50 deaths in the cilta-cel arm and 82 in the SOC arm, with 21 and 51 deaths attributed to progressive disease in these respective arms, Dhakal reports. Overall, this study marks a significant milestone in multiple myeloma treatment, demonstrating a survival benefit with cilta-cel for patients experiencing their first relapse, Dhakal concludes.