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Cited by 282

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Up to 8-year follow-up from RESONATE-2: first-line ibrutinib treatment for patients with chronic lymphocytic leukemia

Open access
Barr, Paul M., Owen, Carolyn, Robak, Tadeusz, Tedeschi, Alessandra, Bairey, Osnat, Burger, Jan A., Hillmen, Peter, Coutre, Steve E., Dearden, Claire, Grosicki, Sebastian, McCarthy, Helen, Li, Jian-Yong, Offner, Fritz, Moreno, Carol, Zhou, Cathy, Hsu, Emily, Szoke, Anita, Kipps, Thomas J., Ghia, Paolo·2022·Blood Advances
DOI 10.1182/bloodadvances.2021006434
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Abstract

We report long-term follow-up from the RESONATE-2 phase 3 study of the once-daily Bruton’s tyrosine kinase inhibitor ibrutinib, which is the only targeted therapy with significant progression-free survival (PFS) and overall survival (OS) benefit in multiple randomized chronic lymphocytic leukemia (CLL) studies. Patients (≥65 years) with previously untreated CLL, without del(17p), were randomly assigned 1:1 to once-daily ibrutinib 420 mg until disease progression/unacceptable toxicity (n = 136) or chlorambucil 0.5-0.8 mg/kg ≤12 cycles (n = 133). With up to 8 years of follow-up (range, 0.1-96.6 months; median, 82.7 months), significant PFS benefit was sustained for ibrutinib vs chlorambucil (hazard ratio [HR], 0.154; 95% confidence interval [CI], 0.108-0.220). At 7 years, PFS was 59% for ibrutinib vs 9% for chlorambucil. PFS benefit was also observed for ibrutinib- vs chlorambucil-randomized patients with high-risk genomic features: del(11q) (HR, 0.033; 95% CI, 0.010-0.107) or unmutated immunoglobulin heavy chain variable region (HR, 0.112; 95% CI, 0.065-0.192). OS at 7 years was 78% with ibrutinib. Prevalence of adverse events (AEs) was consistent with previous 5-year follow-up. Ibrutinib dosing was held (≥7 days) for 79 patients and reduced for 31 patients because of AEs; these AEs resolved or improved in 85% (67 of 79) and 90% (28 of 31) of patients, respectively. With up to 8 years of follow-up, 42% of patients remain on ibrutinib. Long-term RESONATE-2 data demonstrate sustained benefit with first-line ibrutinib treatment for CLL, including for patients with high-risk genomic features. These trials were registered at www.clinicaltrials.gov as #NCT01722487 and #NCT01724346.

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Metadata

Authors
Barr, P. M., Owen, C., Robak, T., Tedeschi, A., Bairey, O., Burger, J. A., Hillmen, P., Coutre, S. E., Dearden, C., Grosicki, S., McCarthy, H., Li, J.-Y., Offner, F., Moreno, C., Zhou, C., Hsu, E., Szoke, A., Kipps, T. J., & Ghia, P.
Venue
Blood Advances
Publisher
American Society of Hematology
Published
2022-06-08
Volume
6
Issue
11
Pages
3440-3450
ISSN
  • 2473-9529 (ISSN-L)
  • 2473-9537
DOI
10.1182/bloodadvances.2021006434
OpenAlex
W4224138250
Cited by
282
References
22
FWCI
30.39
Type
journal article
Language
en
Open access
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CoChat. (2026). Citation check: Up to 8-year follow-up from RESONATE-2: first-line ibrutinib treatment for patients with chronic lymphocytic leukemia. https://app.cochat.ai/papers/10.1182/bloodadvances.2021006434
The paper
Barr, P. M., Owen, C., Robak, T., Tedeschi, A., Bairey, O., Burger, J. A., Hillmen, P., Coutre, S. E., Dearden, C., Grosicki, S., McCarthy, H., Li, J.-Y., Offner, F., Moreno, C., Zhou, C., Hsu, E., Szoke, A., Kipps, T. J., & Ghia, P. (2022). Up to 8-year follow-up from RESONATE-2: first-line ibrutinib treatment for patients with chronic lymphocytic leukemia. Blood Advances. https://doi.org/10.1182/bloodadvances.2021006434

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.