A phase 3 study of ciltacabtagene autoleucel in patients with lenalidomide-refractory multiple myeloma is discussed by Binod Dhakal, MD, MS.
Binod Dhakal, MD, MS, assistant professor of medicine in the Division of Hematology and Oncology at the Medical College of Wisconsin, discusses results from the phase 3 CARTITUDE-4 study (NCT04181827) of ciltacabtagene autoleucel (cilta-cel; Carvykti) in patients with lenalidomide-refractory multiple myeloma.
Cilta-cel achieved a 74% reduction in the risk of disease progression or death compared with standard of care treatment in CARTITUDE-4, according to a presentation given by Dhakal at the 2023 American Society of Clinical Oncology Annual Meeting.
Dhakal says the results show that cilta-cel is highly effective for treating lenalidomide-refractory multiple myeloma. In addition to the progression-free survival advantage, the response rate, and minimal disease negativity rate shown with cilta-cel were also positive.
0:07 | The primary end point of the study was progression-free survival, and we saw cilta-cel significantly reduced the risk of disease progression or death vs standard-of-care by 74%. The hazard ratio was 0.26. The median PFS at 16 months follow-up was not reached in the cilta-cel arm compared with 11.8 months in the standard-of-care arm, and the 12-month PFS rates were 76% in the cilta-cel arm compared with 49% in the standard-of-care arm. We also observed that cilta-cel consistently prolonged the progression-free survival in all subgroups, including the key subgroups of patients with high-risk disease, soft tissue plasmacytoma, and triple-class refractory disease.
0:52 | Cilta-cel led to significantly higher rates of response and default response compared with standard-of-care. The overall response rates are 85% and better in patients with cilta-cel vs 67% with the standard-of-care. When looking at the MRD negativity and the complete response rates, the complete response rates were 72% in the cilta-cel arm vs 22% in the standard-of-care arm, and MRD negativity rates for all patients were 61% in the cilta-cel arm vs 16% in the standard-of-care arm. These results suggest cilta-cel is highly effective and provides superior efficacy responses compared with standard-of-care in the study.