Dr Mateos on Long-Term OS Data From the Phase 3 CARTITUDE-4 Study of Cilta-Cel in Lenalidomide-Refractory Multiple Myeloma

“There was a significant benefit with cilta-cel vs standard of care; over 75% of patients in the cilta-cel arm remained alive at 33.6 months, and the HR for overall survival was 0.55.”

María-Victoria Mateos, MD, PhD, consultant physician, Hematology Department, associate professor of medicine, University of Salamanca, discusses long-term overall survival data from the phase 3 CARTITUDE-4 trial (NCT04181827) of ciltacabtagene autoleucel (cilta-cel; Carvykti) in lenalidomide (Revlimid)-refractory multiple myeloma.

At a median follow-up of 33.6 months (range, 0.1-45.0), data from CARTITUDE-4 presented during the 51st Annual EBMT Meeting showed that patients who received cilta-cel (n = 208) experienced a 45% reduction in the risk of death compared with patients who received standard-of-care (SOC) therapy(n = 211; HR, 0.55; 95% CI, 0.39-0.79; P = .0009); the benefit was sustained across prespecified patient subroups, Mateos said. Additionally, the 30-month OS rates were 76.4% vs 63.8%, respectively. SOC treatment options consisted of either daratumumab (Darzalex) plus pomalidomide (Pomalyst) and dexamethasone (DPd) or pomalidomide plus bortezomib (Velcade) and dexamethasone (PVd).

Treatment with cilta-cel also led to a benefit in progression-free survival (PFS) compared with SOC therapy, Mateos added. The median PFS in the cilta-cel arm was not yet reached (NR), and the 30-month PFS rates in the investigational and control arms were 59.4% vs 25.7%, respectively (HR, 0.29; 95% CI, 0.22-0.39; P < .0001). These data indicate that use of cilta-cel in patients after 1 to 3 prior lines of treatment reduced the risk of disease progression or death by 71%, Mateos says.

Treatment with cilta-cel also led to high complete response (CR) and stringent CR (sCR) rates, Mateos said. These respective rates were 69.2% and 7.7%, respectively, among patients who received the CAR T-cell therapy. The median duration of response (DOR) in the cilta-cel arm was NR (95% CI, not estimable [NE]-NE) vs 18.7 months (95% CI, 12.9-23.7) in the SOC arm. The 30-month DOR rates were 67.4% (95% CI, 59.7%-74.0%) vs 35.5% (95% CI, 27.6%-43.6%), respectively.

The rate of minimal residual disease (MRD) negativity in the cilta-cel arm at thresholds of 10-5 and 10-6 were also significantly higher compared with SOC, Mateos concluded. MRD-evaluable patients in the cilta-cel arm (n = 145) achieved an MRD negativity rate of 89.0% vs 37.9% in the SOC arm (n = 103). These rates at a threshold of 10-6 were 85.6% vs 18.6% in MRD-evaluable patients in the investigational (n = 139) and control (n = 102) arms, respectively.