Dr Lin on Findings From the CARTITUDE-1 Trial in Relapsed/Refractory Multiple Myeloma

Yi Lin, MD, PhD, hematologist, oncologist, Mayo Clinic, discusses findings from the primary analysis of the phase 1/2 CARTITUDE-1 trial (NCT03548207) of the BCMA-targeting CAR T-cell therapy ciltacabtagene autoleucel (cilta-cel; Carvykti) in patients with relapsed/refractory multiple myeloma, highlighting how these preliminary findings contributed to the launch of a subgroup analysis evaluating response rates of patients who achieved minimal residual disease (MRD) negativity.

In 2022, the FDA approved cilta-cel for the treatment of patients with relapsed/refractory multiple myeloma who have received at least 4 prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. This regulatory decision was supported by findings from the single-arm CARTITUDE-1 trial, which evaluated the safety and efficacy of cilta-cel in patients who received a single dose of the CAR T-cell therapy and no maintenance therapy, Lin says.

Findings from the primary analysis of CARTITUDE-1 showed that at a median follow-up of 12.4 months (interquartile range, 10.6-15.2), the overall response rate was 97% (95% CI, 91.2%-99.4%), with a stringent complete response (sCR) rate of 67%. Additionally, the median duration of response (DOR) (95% CI, 15.9-not estimable [NE]) and the median progression-free survival ([PFS] 95% CI, 16.8-NE) were not reached. The 12-month PFS and overall survival rates were 77% (95% CI, 66.0%-84.3%) and 89% (95% CI, 80.2%-93.5%), respectively.

Furthermore, several patients who were evaluable for bone marrow MRD analysis achieved bone marrow MRD negativity, Lin explains. Of the 61 patients evaluable for MRD negativity, 91.8% achieved MRD negativity at any point during the trial.

An analysis of the efficacy outcomes and characteristics of the patients enrolled in CARTITUDE-1 who achieved sustained MRD negativity demonstrated that all patients with sustained MRD negativity for at least 6 months achieved sCR. Moreover, the patients with sustained MRD negativity achieved a longer DOR compared with the patients who did not have sustained MRD negativity.