CARVYKTI® (ciltacabtagene autoleucel) has demonstrated promising results in patients with functional high-risk multiple myeloma who have received only one prior line of therapy. A subanalysis of the CARTITUDE-4 trial indicates that cilta-cel significantly improves outcomes compared to standard of care, offering a potential new option for these high-risk patients.
Improved Outcomes with Cilta-Cel
The CARTITUDE-4 study (NCT04181827) included patients who had received 1 to 3 prior lines of therapy, including a proteasome inhibitor (like bortezomib) and an immunomodulatory drug (like pomalidomide), and who were refractory to lenalidomide. The subanalysis focused on 79 patients with functional high-risk myeloma who had received only one prior line of therapy. Functional high-risk myeloma is defined as relapse within 18 months of initial treatment or within 12 months of first autologous stem cell transplantation and is associated with poor prognosis.
Key findings from the subanalysis reveal that cilta-cel significantly outperformed standard care. The overall response rate was higher in the cilta-cel group, with 67% achieving a complete response or better, compared to 38% in the standard of care group. This indicates a greater proportion of patients achieving deep remissions with cilta-cel.
Progression-Free Survival
Patients treated with cilta-cel showed a 73% reduction in the risk of disease progression or death. After one year, 77% of patients in the cilta-cel group remained in response, compared to only 49% in the standard of care group. These results highlight the potential of cilta-cel to provide durable responses in this high-risk population.
Safety Profile
While cilta-cel is associated with potential side effects such as low blood counts, cytokine release syndrome, and neurotoxicity, the study found that these side effects were relatively manageable, particularly in patients treated after only one prior line of therapy. The toxicity levels observed in these patients were similar to those seen in patients treated at later stages of their disease, suggesting that cilta-cel can be safely administered earlier in the treatment course.
Expert Commentary
According to myeloma specialist Dr. Luciano Costa from the University of Alabama, Birmingham, the CARTITUDE-4 trial supports the approval of ciltacabtagene autoleucel (cilta-cel, Carvykti, Johnson & Johnson). The study's findings suggest that cilta-cel could offer better outcomes and has a manageable safety profile, making it a potential option to discuss with healthcare providers.
