By 3 months post-randomization, there were 31 PFS events in the cilta-cel arm and 27 in the SOC arm,” Dhakal explained. “During the time when both arms were the same treatment, there is an imbalance in early PFS events, with 22 in the cilta-cel arm and 8 in the SOC arm. Notably, patients in the cilta-cel arm received the same treatment as the SOC arm during the bridging phase prior to the infusion of the CAR T-cell therapy. Five to 7 days following lymphodepletion with 300 mg/m 2 of cyclophosphamide and 30 mg/m 2 of fludarabine per day for 3 days, patients in the experimental arm received cilta-cel at a target dose of 0.75 x 10 6 CAR+ T cells/kg. In the cilta-cel arm, patients received at least 1 cycle of bridging therapy with PVd or DPd following apheresis. Patients were randomly assigned 1:1 to receive cilta-cel or SOC with physician’s choice of PVd or DPd. Prior CAR T-cell therapy or BCMA-targeted therapy was not allowed. Patients needed to have an ECOG performance status of 0 or 1. 3ĬARTITUDE-4 enrolled patients at least 18 years of age with multiple myeloma who had received 1 to 3 prior lines of therapy, including a PI and an IMiD, who were refractory to lenalidomide. “Cilta-cel has the potential to be a new standard of care for patients with lenalidomide-refractory myeloma after first relapse,” lead study author Binod Dhakal, MD, an associate professor at the Medical College of Wisconsin in Milwaukee, said in a presentation of the data.Ĭilta-cel was approved by the FDA in February 2022 for the treatment of adult patients with relapsed/refractory multiple myeloma following 4 or more prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody, based on data from the phase 1b/2 CARTITUDE-1 trial (NCT03548207). The 12-month PFS rate was 76% in the cilta-cel arm and 49% in the SOC arm. 1,2įindings presented at the 2023 ASCO Annual Meeting and simultaneously published in the New England Journal of Medicine showed that at a median follow-up of 15.9 months (range 0.1-27), patients treated with cilta-cel (n = 208) experienced a median PFS that was not yet reached (NR 95% CI, 22.8 months-not estimable ) compared with 11.8 months (95% CI, 9.7-13.8) in those given SOC (n = 211 HR, 0.26 95% CI, 0.18-0.38 P <. In the phase 3 CARTITUDE-4 trial (NCT04181827), treated with ciltacabtagene autoleucel (cilta-cel Carvykti) led to significant improvement in progression-free survival (PFS) over standard-of-care (SOC) pomalidomide (Pomalyst), bortezomib (Velcade), and dexamethasone (PVd) or daratumumab (Darzalex), pomalidomide, and dexamethasone (DPd) in patients with lenalidomide (Revlimid)-refractory multiple myeloma who received 1 to 3 prior lines of therapy.
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