Does earlier cilta-cel treatment improve outcomes in MM?

Long-term data of the CARTITUDE-4 study suggest that ciltacabtagene autoleucel (cilta-cel) may have curative potential in patients with standard-risk relapsed or refractory multiple myeloma (MM). In addition, earlier use of cilta-cel appears to further improve survival outcomes in this population.

CARTITUDE-4 (NCT04181827) randomised 419 adults with MM who had received 1–3 prior lines of therapy, were lenalidomide-refractory, and had an Eastern Cooperative Oncology Group (ECOG) performance status ≤1 to standard-of-care regimens or cilta-cel in a 1:1 ratio. Previously reported topline results demonstrated that cilta-cel significantly improved survival outcomes irrespective of cytogenetic risk [1]. The current analysis focused on 59 cilta-cel–treated participants with standard-risk cytogenetics and 46 participants with isolated gain/amplification (1q). “We only included as-treated participants,” noted Prof. Luciano Costa (University of Alabama, AL, USA), who presented the updated findings [2].

Among these 105 participants, the overall response was 100%, with 92% achieving a complete response or better. At 30 months, the progression-free survival (PFS) rate was 80.5% in the standard-risk group and 71.7% when including those with gain/amplification (1q). The corresponding 30-month overall survival rates were 87.3% and 86.1%, respectively.

Prof. Costa compared the PFS rates of these CARTITUDE-4 participants with similarly risk-stratified participants from the CARTITUDE-1 trial (NCT03548207), highlighting improved PFS when cilta-cel was administered earlier in the treatment sequence (71.7% vs 59.9%). “In CARTITUDE-4, participants had received a median of 2 prior lines of therapy, whereas participants in CARTITUDE-1 had been treated with a median of 6 prior lines of therapy,” he explained. The respective overall survival rates (86.1% vs 70.6%) further support the observation that earlier intervention with cilta-cel leads to improved survival.

Finally, the safety profile of cilta-cel in participants with standard-risk cytogenetics was consistent with the overall findings from the CARTITUDE-4 trial.

“The low rate of progression events in patients with standard-risk relapsed or refractory MM is indicative of a potential cure fraction,” concluded Prof. Costa. “Furthermore, earlier treatment with cilta-cel improved survival outcomes for patients with standard-risk disease.”

1. San-Miguel J, et al. NEJM. 2023;389(4):335-347.
2. Costa L, et al. Long-term progression-free survival benefit with ciltacabtagene autoleucel in standard-risk relapsed/refractory multiple myeloma. Abstract 94, American Society of Hematology (ASH) annual meeting 2025, 6–9 December, Orlando, Florida, USA.

Medical writing support was provided by Robert van den Heuvel.
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Posted on 9 December 202522 December 2025