Key Findings From the CARTITUDE-4 Trial of Cilta-Cel in Multiple Myeloma
Binod Dhakal, MD, MS, discusses the safety and efficacy findings from the CARTITUDE-4 trial.
Binod Dhakal, MD, MS, assistant professor of medicine in the Division of Hematology and Oncology at the Medical College of Wisconsin, discusses the safety and efficacy findings from the CARTITUDE-4 trial (NCT04181827).
CARTITUDE-4 is a phase 3, randomized study evaluating treatment with the chimeric antigen receptor (CAR) T-cell therapy ciltacabtagene autoleucel (cilta-cel; Carvykti) in patients with lenalidomide (Revlimid)-refractory multiple myeloma who had received at least 1 prior line of therapy.
Updated results were presented at the 2024 International Myeloma Society Annual Meeting, showing that cilta-cel reduced the risk of death by 45% vs standard of care (SOC) in this patient population. At a median follow-up of 33.6 months (range, 0.1-45.0), cilta-cel led to a 30-month overall survival (OS) rate of 76.4% vs 63.8% with SOC (HR, 0.55; 95% CI, 0.39-0.79; P = .0009), which consisted of physician’s choice of pomalidomide (Pomalyst), bortezomib (Velcade), and dexamethasone, or daratumumab (Darzalex) plus pomalidomide and dexamethasone.
Transcription:
0:09 | In the study, a total of 419 patients were randomized, cilta-cel patients were 208 and standard of care was 211. In this updated follow-up at 33.6 months, we observed significant benefit with cilta-cel in terms of overall survival compared [with] standard of care, with the hazard ratio of .55. The median overall survival was not reached with cilta-cel or the standard of care, and the 30-month overall survival rates were 76% with cilta-cel vs 64% in the standard of care arm.
0:45 | Importantly, this overall survival benefit [was in] all the previously specified subgroups, including the patients with high-risk cytogenetics, whose extremity of disease is stage III. In terms of progression-free survival at a 15 month follow-up, the median progression-free survival was not reached in the cilta-cel arm, and was 11.8 months in the standard of care arm, and at this longer follow-up, the median progression-free survival was still not reached in the cilta-cel arm, and was 11.8 months in the standard of care arm, with the hazard ratio of .29. The median time to symptom worsening was also not reached with cilta-cel and was 34.3 months with the standard of care arm.
1:27 | Safety was consistent with the previous interim analysis, with no new safety signal in terms of delayed neurotoxicity. Deaths occurred in 50 and 82 patients in the cilta-cel and standard of care groups, respectively, and 21 and 51 died due to progressive disease.
1:46 | In summary, this longer follow-up at 33.6 months shows that cilta-cel significantly reduces the risk of death and delayed symptom worsening or standard of care in patients with lenalidomide-refractory multiple myeloma as early as first relapse. This is the first study in multiple myeloma where CAR T has shown significant survival benefit compared [with] standard of care in patients.
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