CARTITUDE-4
The first randomised trial to show a CAR-T improves survival in myeloma, as early as second line.
PFS HR 0.26 (12-month PFS 76% vs 49%); OS HR 0.55 at 34 months (ASCO 2024); MRD negativity 87% vs 33% among evaluable. Approved for ≥1 prior line April 2024.
Setting
Lenalidomide-refractory myeloma after 1-3 prior lines: cilta-cel vs Pom-Vd or Dara-Pd
Phase
Phase 3
Sponsor
Janssen / Legend
Registry
Headline result
PFS HR 0.26; OS HR 0.55.
Reported
2023
Enrolled
419
Replication
KarMMa-3 (ide-cel) showed a PFS benefit of similar direction but smaller size (HR 0.49) without a clear OS benefit.
In plain words
What these results mean for people, not percentages
Progression-free survivalprimarysurrogate endpoint
- The treated group had about 74 percent lower chance of the event at any given time (hazard ratio 0.26).
- The absolute difference, how many more people out of 100 were helped, is not reported here.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
Overall survivalsurvival endpoint
- The treated group had about 45 percent lower chance of the event at any given time (hazard ratio 0.55).
- The absolute difference, how many more people out of 100 were helped, is not reported here.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Be careful
- These results apply to the people the trial enrolled: Lenalidomide-refractory myeloma after 1-3 prior lines: cilta-cel vs Pom-Vd or Dara-Pd. People in a different situation may not see the same effect.
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 participants enrolled.
Overall survival
HR 0.55 (0.39–0.79)
Numbers not yet public.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Cilta-cel | 208 | — | 0.26 (0.18–0.38) | <0.001 | link |
| Standard care | 211 | — | ||||
| Overall survival | Cilta-cel | — | — | 0.55 (0.39–0.79) | — | — |
| Standard care | — | — |
Replication
KarMMa-3 (ide-cel) showed a PFS benefit of similar direction but smaller size (HR 0.49) without a clear OS benefit.