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Cilta-cel induced sustained remission in RRMM, suggesting curative potential after a single infusion. 

A long-term study published in the June 2025 issue of Journal of Clinical Oncology; researchers conducted a retrospective study to assess the long-term efficacy and safety of ciltacabtagene autoleucel (cilta-cel) in patients with heavily pretreated relapsed or refractory multiple myeloma (RRMM).  

They carried out a long-term follow-up study with a median duration of 61.3 months to evaluate overall survival (OS), ≥5-year progression-free outcomes, safety, and associated biomarkers in 97 patients with RRMM who received cilta-cel. Median OS was 60.7 months (95% CI 41.9 to not estimable). Of these, 32 out of 97 patients (33%) remained alive and progression-free for ≥5 years following a single cilta-cel infusion without maintenance therapy. At a single center, 12 of the 32 underwent serial minimal residual disease (MRD) testing and positron emission tomography–computed tomography; all were MRD-negative (at least 10^-5 threshold) and imaging-negative at or beyond year 5.  

The results showed that 100% of patients (12/12) had MRD-negative (at least 10^-5 threshold) and imaging-negative at year 5 or later after receiving cilta-cel. Baseline features such as high-risk cytogenetics and extramedullary disease were largely similar between the 32 patients who remained progression-free for ≥5 years and those with progression by year 5. A pattern of lower baseline tumor burden, higher proportions of naïve T-cells in the cilta-cel product, elevated T cell-to-neutrophil ratios, increased baseline hemoglobin and platelet levels, and greater effector-to-target cell ratios were linked with ≥5-year progression-free survival (PFS).  

Investigators concluded that cilta-cel exhibited a consistent safety profile and showed potential curative benefit in patients with RRMM. 

Source: ascopubs.org/doi/10.1200/JCO-25-00760