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The first randomised trial to show a CAR-T improves survival in myeloma, as early as second line.
CARTITUDE-4, trial NCT04181827 sponsored by Janssen and Legend and published in the New England Journal of Medicine in 2023, was the first randomised trial to show that a CAR-T improves survival in myeloma, as early as the second line. It randomised 419 lenalidomide-refractory patients after one to three prior lines to ciltacabtagene autoleucel or standard combinations, met its primary progression-free survival endpoint with a very large effect, showed an overall survival benefit at ASCO 2024 and far higher MRD negativity, and led to approval for patients with at least one prior line in April 2024. Whether CAR-T should replace transplant in the frontline, which CARTITUDE-5 and CARTITUDE-6 test, is the open question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
419 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Cilta-cel | 208 | - | 0.26 (0.18 to 0.38) | <0.001 | link |
| Standard care | 211 | - | ||||
| Overall survival | Cilta-cel | - | - | 0.55 (0.39 to 0.79) | - | link |
| Standard care | - | - |
Shares Legend Biotech, LEGEND-2, Ciltacabtagene autoleucel, Relapsed or refractory multiple myeloma.
Shares One CAR-T infusion instead of autologous transplant, CARTITUDE-4: cilta-cel CAR-T versus standard combinations after one to three prior lines of myeloma therapy, Ciltacabtagene autoleucel, Johnson & Johnson.
Shares Legend Biotech, CARTITUDE-4: cilta-cel CAR-T versus standard combinations after one to three prior lines of myeloma therapy, Ciltacabtagene autoleucel, Johnson & Johnson.
Shares Legend Biotech, LEGEND-2, Ciltacabtagene autoleucel.
Shares Hospital-made CAR-T under one shared regulatory master file, Hospital-based CAR-T manufacturing at cost through a public network, Relapsed or refractory multiple myeloma, CAR-T cell therapy.
Shares Hospital-made CAR-T under one shared regulatory master file, Hospital-based CAR-T manufacturing at cost through a public network, Relapsed or refractory multiple myeloma, CAR-T cell therapy.
Shares Hospital-made CAR-T under one shared regulatory master file, Hospital-based CAR-T manufacturing at cost through a public network, Relapsed or refractory multiple myeloma, CAR-T cell therapy.
Shares Legend Biotech, Ciltacabtagene autoleucel, Johnson & Johnson, CAR-T cell therapy.