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The trial that made a daily pill the standard for relapsed CLL, cutting the risk of progression by nearly 80%.
RESONATE, trial NCT01578707 sponsored by Pharmacyclics and Janssen and published in the New England Journal of Medicine in 2014, is the trial that made a daily tablet the standard for relapsed chronic lymphocytic leukaemia, cutting the risk of progression by nearly eighty percent. It randomised 391 patients with relapsed or refractory CLL to ibrutinib or ofatumumab, met its primary progression-free survival endpoint at the interim analysis with a survival benefit as well, and the six-year follow-up showed the advantage maintained including in del(17p) and unmutated IGHV disease, the basis of the 2014 CLL approval. OnCo links it to chronic lymphocytic leukaemia, BTK as a target, ibrutinib, John C. Byrd and The Ohio State University cancer centre. Whether continuous therapy or fixed-duration combinations serve patients better is the question the field has moved on to.
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 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Ibrutinib | 195 | - | 0.22 (0.15 to 0.32) | <0.001 | link |
| Ofatumumab | 196 | - | ||||
| Progression-free survival (median, 6-year follow-up) | Ibrutinib | - | 44.1 months | - | - | link |
| Ofatumumab | - | 8.1 months |
Shares Ibrutinib, AbbVie (incl. ImmunoGen, Capstan), Johnson & Johnson, Chronic lymphocytic leukaemia.
Shares Relapsed or refractory chronic lymphocytic leukaemia, BTK (Bruton tyrosine kinase), Ibrutinib, Chronic lymphocytic leukaemia.
Shares Ibrutinib, AbbVie (incl. ImmunoGen, Capstan), Johnson & Johnson, Chronic lymphocytic leukaemia.
Shares Relapsed or refractory chronic lymphocytic leukaemia, Ibrutinib, Chronic lymphocytic leukaemia, Small-molecule kinase inhibitors.
Shares Relapsed or refractory chronic lymphocytic leukaemia, AbbVie (incl. ImmunoGen, Capstan), Chronic lymphocytic leukaemia, Small-molecule kinase inhibitors.
Shares John C. Byrd, BTK (Bruton tyrosine kinase), Chronic lymphocytic leukaemia, Small-molecule kinase inhibitors.
Shares Ibrutinib, AbbVie (incl. ImmunoGen, Capstan), Johnson & Johnson, Small-molecule kinase inhibitors.