CARTITUDE-1 Closeout Data Show Significant PFS Benefit of CAR-T

Patients with relapsed or refractory multiple myeloma (MM) had longer median progression-free survival (PFS) after a single infusion of the chimeric antigen receptor (CAR) T-cell therapy ciltacabtagene autoleucel than any other previously reported therapy, according to the final results of CARTITUDE-1.

Median PFS was 34.9 months, with about half (47.5%) of patients alive at 36 months, according to a poster presentation from Yi Lin, MD, PhD, of Mayo Clinic in Rochester, Minnesota, and colleagues at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

Ciltacabtagene autoleucel gained US Food and Drug Administration approval for relapsed or refractory MM in February 2022 based on the initial results of CARTITUDE-1.

In the study, 97 heavily pretreated patients received an infusion of ciltacabtagene autoleucel. Patients had three or more prior lines of therapy or were double refractory to a proteasome inhibitor (PI) and immunomodulatory drug (IMiD), and had received prior PI, IMiD, and anti-CD38 antibody therapy.

The median duration of response was 33.9 months. Median overall survival is not reached for this group. At 36 months, the estimated overall survival rate was 62.9%.

Forty-nine of the 97 patients were measurable residual disease (MRD) evaluable. Of these, 26 had MRD negativity sustained for 12 months or longer. The median PFS for these patients is not reached. Eighteen patients were MRD negative with a complete response or better at two years post-infusion.

The researchers reported no new safety signals with ciltacabtagene autoleucel. There were six cases of second primary malignancy; these included two cases of basal cell carcinoma and one case of myelodysplastic syndromes, B-cell lymphoma, melanoma, and prostate cancer. Five additional deaths have occurred since the median follow-up of 27.7 months, for a total of 35; seventeen of these are unrelated to ciltacabtagene autoleucel .

The ongoing, long-term CARTITUDE study will continue to follow these patients for safety and survival.

Reference

Lin Y, Martin T, Usmani S, et al. CARTITUDE-1 final results: phase 1b/2 study of ciltacabtagene autoleucel in heavily pretreated patients with relapsed/refractory multiple myeloma. Abstract #8009. Presented at the 2023 American Society of Clinical Oncology Annual Meeting; June 2-6, 2023; Chicago, Illinois.