Updated Results from CARTITUDE-1 Trial Show Continued Efficacy of Ciltacabtagene Autoleucel in Treating Relapsed/Refractory Multiple Myeloma

By DocWire News Editors - Last Updated: August 31, 2023

A study reported updated results from the CARTITUDE-1 trial, which previously showed that cilacabtagene autoleucel (cilta-cel) demonstrated early, deep, and durable responses in patients with relapsed/refractory multiple myeloma that had been heavily pretreated. The study was conducted by Thomas Martin, MD, and colleagues and was presented at the 2021 American Society of Hematology Annual Meeting.

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The study sought to characterize cilta-cel safety, confirm the recommended phase II dose (from phase Ib), and evaluate cilta-cel efficacy (phase II). Researchers assessed 97 eligible patients with myeloma who received three or more prior therapies; whose disease was refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD); and who had received a PI, IMiD, and an anti-CD38 antibody. The study population were administered a single cilta-cel infusion over 5 to 7 days following lymphodepletion.

The results show that, as of a data cut-off of February 11, 2021, the population of interest had received a median of six prior lines of therapy. The treatment has demonstrated robust efficacy, with an objective response rate (ORR) of 97.9%. The investigators observed that more than 80% of patients achieved stringent complete response (sCR), and around 95% achieved very good partial response or better. They noted that the median time to first response was 1 month (range = 0.9-10.7), suggesting rapid response. The median time to best response was 2.6 months (range = 0.9-15.2), and the median time to CR or better was also 2.6 months (range = 0.9-15.2).

Responses also appeared to be durable, with a median duration of response of 21.8 months, according to the researchers. The 18-month progression-free and overall survival rates were 66% and 80.9%, respectively.

In terms of the treatment’s safety profile, the most common grade 3/4 hematologic adverse events (AEs; occuring in ≥25% of patients) were neutropenia (94.8%), anemia (68.0%), leukopenia (60.8%), thrombocytopenia (59.8%), and lymphopenia (49.5%). There were no patient deaths related to cytopenias and no new safety signals.

The researchers concluded that, “cilta-cel demonstrated a manageable safety profile with no new safety signals observed with longer follow-up. Further investigations of cilta-cel are ongoing in earlier lines of therapy and in outpatient settings.”

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