RESONATE
The trial that made a daily pill the standard for relapsed CLL, cutting the risk of progression by nearly 80%.
PFS HR 0.22 (95% CI 0.15-0.32) at interim; OS HR 0.43; 6-year follow-up: median PFS 44.1 vs 8.1 months, benefit maintained in del(17p) and unmutated IGHV. NEJM 2014. Basis of the 2014 CLL approval.
- The treated group had about 78 percent lower chance of the event at any given time (hazard ratio 0.22).
- The absolute difference, how many more people out of 100 were helped, is not reported here.
- Median 44.1 vs 8.1 months with Ibrutinib compared with Ofatumumab; about 36 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- 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.
- These results apply to the people the trial enrolled: Relapsed or refractory CLL/SLL: ibrutinib vs ofatumumab. 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.
391 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Ibrutinib | 195 | — | 0.22 (0.15–0.32) | <0.001 | link |
| Ofatumumab | 196 | — | ||||
| Progression-free survival (median, 6-year follow-up) | Ibrutinib | — | 44.1 months | — | — | — |
| Ofatumumab | — | 8.1 months |
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not linked directly; found by shared links- TrialALPINE
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