The DOI matches its Crossref record; 33 of the 33 references it cites were found in a registry or an index.
Final analysis from RESONATE: Up to six years of follow‐up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma
Open accessAbstract
Ibrutinib, a once‐daily oral inhibitor of Bruton's tyrosine kinase, is approved in the United States and Europe for treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The phase 3 RESONATE study showed improved efficacy of single‐agent ibrutinib over ofatumumab in patients with relapsed/refractory CLL/SLL, including those with high‐risk features. Here we report the final analysis from RESONATE with median follow‐up on study of 65.3 months (range, 0.3‐71.6) in the ibrutinib arm. Median progression‐free survival (PFS) remained significantly longer for patients randomized to ibrutinib vs ofatumumab (44.1 vs 8.1 months; hazard ratio [HR]: 0.148; 95% confidence interval [CI]: 0.113‐0.196; P ˂.001). The PFS benefit with ibrutinib vs ofatumumab was preserved in the genomic high‐risk population with del(17p), TP53 mutation, del(11q), and/or unmutated IGHV status (median PFS 44.1 vs 8.0 months; HR: 0.110; 95% CI: 0.080‐0.152), which represented 82% of patients. Overall response rate with ibrutinib was 91% (complete response/complete response with incomplete bone marrow recovery, 11%). Overall survival, censored for crossover, was better with ibrutinib than ofatumumab (HR: 0.639; 95% CI: 0.418‐0.975). With up to 71 months (median 41 months) of ibrutinib therapy, the safety profile remained consistent with prior reports; cumulatively, all‐grade (grade ≥3) hypertension and atrial fibrillation occurred in 21% (9%) and 12% (6%) of patients, respectively. Only 16% discontinued ibrutinib because of adverse events (AEs). These long‐term results confirm the robust efficacy of ibrutinib in relapsed/refractory CLL/SLL irrespective of high‐risk clinical or genomic features, with no unexpected AEs. This trial is registered at www.clinicaltrials.gov (NCT01578707).
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Self-citationGenomic Aberrations and Survival in Chronic Lymphocytic Leukemia
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Self-citationIbrutinib versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia
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Obinutuzumab plus Chlorambucil in Patients with CLL and Coexisting Conditions
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Cited by
Zanubrutinib or Ibrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia
Brown, J. R., Eichhorst, B., Hillmen, P., Jurczak, W., Kaźmierczak, M., Lamanna, N., O’Brien, S. M., Tam, C. S., Qiu, L., Zhou, K., et al. (2023) · New England Journal of Medicine · doi:10.1056/nejmoa2211582 · Cited by 489
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Self-citationComparative Analysis of BTK Inhibitors and Mechanisms Underlying Adverse Effects
Estupiñán, H. Y., Berglöf, A., Zain, R., & Smith, C. I. E. (2021) · Frontiers in Cell and Developmental Biology · doi:10.3389/fcell.2021.630942 · Cited by 267
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Metadata
- Authors
- Munir, T., Brown, J. R., O'Brien, S., Barrientos, J. C., Barr, P. M., Reddy, N. M., Coutre, S., Tam, C. S., Mulligan, S. P., Jaeger, U., Kipps, T. J., Moreno, C., Montillo, M., Burger, J. A., Byrd, J. C., Hillmen, P., Dai, S., Szoke, A., Dean, J. P., & Woyach, J. A.
- Venue
- American Journal of Hematology
- Publisher
- Wiley
- Published
- 2019-10-13
- Volume
- 94
- Issue
- 12
- Pages
- 1353-1363
- ISSN
- 0361-8609 (ISSN-L)
- 1096-8652
- OpenAlex
- W2973195462
- Cited by
- 473
- References
- 33
- FWCI
- 24.54
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Munir, T., Brown, J. R., O'Brien, S., Barrientos, J. C., Barr, P. M., Reddy, N. M., Coutre, S., Tam, C. S., Mulligan, S. P., Jaeger, U., Kipps, T. J., Moreno, C., Montillo, M., Burger, J. A., Byrd, J. C., Hillmen, P., Dai, S., Szoke, A., Dean, J. P., & Woyach, J. A. (2019). Final analysis from RESONATE: Up to six years of follow‐up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma. American Journal of Hematology. https://doi.org/10.1002/ajh.25638
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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.
