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Final Analysis From CARTITUDE-1 Trial of Ciltacabtagene Autoleucel in Resistant Myeloma

By: Julia Fiederlein Cipriano
Posted: Monday, July 24, 2023

In heavily pretreated patients with relapsed or refractory multiple myeloma, a single infusion of the B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell therapy ciltacabtagene autoleucel demonstrated a longer median duration of progression-free survival than any previously reported therapy, according to Yi Lin, MD, PhD, of the Mayo Clinic, Rochester, Minnesota, and colleagues. The final results of the phase Ib/II CARTITUDE-1 trial, representing a median follow-up of 33.4 months, were presented during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 8009).

A total of 97 patients who received a median of six prior lines of therapy—including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody—were administered a single infusion of ciltacabtagene autoleucel. The median duration of progression-free survival was 34.9 months; an estimated 47.5% of patients were alive and without disease progression at 36 months. The median duration of overall survival was not reached, with an estimated 36-month rate of 62.9%.

Of the 49 patients who were evaluable for measurable residual disease (MRD), 26 demonstrated sustained negativity at a threshold of 10-5 cells for at least 12 months, including 20 who achieved a sustained MRD-negative complete response or better; the median duration of progression-free survival was not reached in these subgroups. At 24 months after infusion, 18 patients achieved MRD negativity with a complete response or better.

Since the final protocol-specified analysis, which was conducted after a median follow-up of 27.7 months, no new safety signals or neurotoxicity events have been reported. Six new cases of second primary malignancy were documented, including two cases of basal cell carcinoma and one case each of myelodysplastic syndrome, B-cell lymphoma, melanoma, and prostate cancer. The investigators reported 5 additional deaths, resulting in a total of 35 fatalities.

“Patients continue to be followed for safety and survival in the 15-year CARTINUE long-term study,” the investigators remarked.

Disclosure: For full disclosures of the study authors, visit

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