Cilta-Cel’s Prolonged Impact: Deep Responses and Safety Insights from Earlier Lines of Therapy in Multiple Myeloma

CARVYKTI (ciltacabtagene autoleucel) is a B-cell maturation antigen (BCMA)-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s T cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. The data presented from the CARTITUDE-2 trial cohorts A and B, at the ASH 2023 conference revealed that, with a median follow-up of approximately 29 months, patients, including those with lenalidomide-refractory multiple myeloma after one to three lines of therapy (cohort A) and those with early relapse (cohort B), exhibited profound and enduring responses to CARVYKTI. In both cohorts, comprising 20 patients in cohort A and 19 in cohort B, CARVYKTI treatment achieved remarkable overall response rates of 95% and 100%, respectively. Furthermore, the median progression-free survival (PFS) was not reached in either cohort, and the 24-month PFS rates were 75 % in cohort A and 73% in cohort B. Additionally, the respective 24-month overall survival rates were 75% and 84%.

Regarding safety evaluation, no novel safety signals related to CAR-T were detected, except for one additional case of CAR-T cell-related neurotoxicity presenting as sensory loss (Grade 2) in cohort B, which subsequently resolved.

Therapywise Market Size of Multiple Myeloma in fourth-line and above in the United States in 2023

KOL insights

“The data presented at ASH highlight our commitment to pursue the development of cutting-edge therapies with the intent of providing clinically meaningful real-life benefits for patients, in addition to robust efficacy and safety data. These analyses add to the continued evidence from the CARTITUDE-4 study and build our confidence in the profile of CARVYKTI as a potential and promising treatment option for patients with multiple myeloma whose disease recurs early.” –Expert Opinion.

Conclusion

The updated follow-up details underscore that patients treated with ciltacabtagene autoleucel in earlier treatment lines, encompassing those with lenalidomide-refractory multiple myeloma after one to three treatment lines (cohort A) and those encountering early relapse (cohort B), achieved substantial and enduring responses. Notably, there were no new safety signals associated with CAR-T, except for an additional occurrence of CAR-T cell-related neurotoxicity noted in cohort B. The insights from Cohort A offer a glimpse into potential extended survival outcomes, providing valuable context for the ongoing Phase III CARTITUDE-4 trial, which includes the same patient population but currently has a shorter follow-up duration.

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