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First-line treatment with ibrutinib in patients with CLL/SLL: Final results from the RESONATE-2 trial
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The phase III RESONATE-2 trial (NCT01722487) assessed the safety and efficacy of ibrutinib vs chlorambucil in adult patients with untreated CLL/SLL.1 The final 10-year follow-up results of this trial were presented at the SOHO 2024 Annual Meeting by Burger.1
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| Key learnings |
| At 8 years, the ORR and CR/CRi rates increased to 92% and 36%, respectively, in the ibrutinib arm and remained stable thereafter. |
| At 9 years, PFS rates were higher in the ibrutinib arm compared with the chlorambucil arm (49.7% vs 4.4%), and the OS rate was 68.0% (95% CI, 58.6-75.7). |
| At the time of the final analysis, median OS was not estimable and median PFS was 8.9 years. |
| No new safety signals for ibrutinib were reported during this long-term follow-up. Of the 34 patients who experienced AEs of any grade leading to dose reduction, 28 had all AEs resolved. |
| Data from the RESONATE-2 trial demonstrates the durable clinical efficacy and tolerable safety profile of ibrutinib vs chlorambucil, supporting its use in older adult patients with untreated CLL/SLL, including those with high-risk disease features. |
Abbreviations: AE, adverse event; CI, confidence interval; CLL, chronic lymphocytic leukemia; CR, complete response; CRi, CR with incomplete blood count recovery; ORR, overall response rate; OS, overall survival; PFS, progression free survival; SLL, small lymphocytic lymphoma; SOHO, Society of Hematologic Oncology.
- Burger J. Final analysis of the RESONATE-2 study: Up to 10 years of follow-up of first-line ibrutinib treatment in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma. Poster #CLL-076. Presented at: Society of Hematologic Oncology 2024 Annual Meeting; Sep 4–7, 2024; Houston, US.
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