Journal article
Long-term follow-up of the RESONATE phase 3 trial of ibrutinib vs ofatumumab
JC Byrd, P Hillmen, S O'Brien, JC Barrientos, NM Reddy, S Coutre, CS Tam, SP Mulligan, U Jaeger, PM Barr, RR Furman, TJ Kipps, P Thornton, C Moreno, M Montillo, JM Pagel, JA Burger, JA Woyach, S Dai, R Vezan Show all
Blood | AMER SOC HEMATOLOGY | Published : 2019
Abstract
Ibrutinib, a once-daily oral inhibitor of Bruton tyrosine kinase, has greatly improved outcomes for patients with chronic lymphocytic leukemia (CLL). The phase 3 RESONATE trial, which compared single-agent ibrutinib to ofatumumab in high-risk, relapsed patients with CLL, provided support for approval of ibrutinib in the United States and Europe. We describe long-term follow-up of patients treated in RESONATE, where continued superiority of progression-free survival (PFS) (hazard ratio [HR], 0.133; 95% confidence interval [CI], 0.099-0.178) was observed. Overall survival benefit continues (HR, 0.591; 95% CI, 0.378-0.926), although with decreased magnitude relative to that seen before crossove..
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Awarded by National Cancer Institute
Funding Acknowledgements
The authors thank the patients who participated in this study and their supportive families, as well as the investigators, subinvestigators, and coordinators at each of the study sites. The authors thank Joris Diels of Janssen and Suzy Van Sanden of HEMAR, Janssen-Cilag Ltd (Beerse, Belgium) for their work in generating the crossover-adjusted OS analysis using the rank-preserving structural failure time method. Editorial support was provided by Melanie Sweetlove and was funded by Pharmacyclics LLC, an AbbVie Company. This study was sponsored by Pharmacyclics LLC, an AbbVie Company, and Janssen Pharmaceuticals. J.C. Byrd is supported by the Four Winds Foundation, D. Warren Brown Foundation, Judy and Michael Thomas, the Sullivan CLL Research Foundation, and the National Institutes of Health, National Cancer Institute (grants R35 CA197734 and R01 CA177292).