Panelists discuss how CARTITUDE-1 addressed an unmet need by targeting late-line, refractory myeloma patients with a fixed dose of chimeric antigen receptor (CAR) T-cell therapy for potential accelerated approval.
The CARTITUDE-1 study was specifically designed for accelerated approval, given the unmet need in relapsed/refractory multiple myeloma. With a fixed dose of ciltacabtagene autoleucel (cilta-cel) and promising results from prior studies, the trial quickly moved forward.
Participants were confirmed to be refractory to standard treatments, emphasizing the significance of any observed clinical responses. Most had exhausted all standard therapeutic classes, making the observed responses especially noteworthy.
Contextual comparisons with registries like LocoMMotion helped validate the benefits of CAR T-cell therapy, as typical outcomes without it were dismal. This strengthens the evidence base for cilta-cel as a transformative option in late-line settings.
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