Abstract
A pooled analysis of 1238 patients with chronic lymphocytic leukemia/small lymphocytic lymphoma from three phase 3 studies found that genomic risk factors were not associated with shorter progression-free survival (PFS) or overall survival for patients treated with ibrutinib. Ibrutinib-treated patients with del(11q) were found to have a longer PFS than those without del(11q). These results suggest less prognostic relevance for certain genomic risk factors with ibrutinib treatment.
Original language | English (US) |
---|---|
Pages (from-to) | 715-722.e6 |
Journal | Clinical Lymphoma, Myeloma and Leukemia |
Volume | 19 |
Issue number | 11 |
DOIs | |
State | Published - Nov 2019 |
Keywords
- Prognostic factors
- Risk factors
- Small lymphocytic lymphoma
- Survival
ASJC Scopus subject areas
- Hematology
- Oncology
- Cancer Research
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In: Clinical Lymphoma, Myeloma and Leukemia, Vol. 19, No. 11, 11.2019, p. 715-722.e6.
Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - Long-Term Studies Assessing Outcomes of Ibrutinib Therapy in Patients With Del(11q) Chronic Lymphocytic Leukemia
AU - Kipps, Thomas J.
AU - Fraser, Graeme
AU - Coutre, Steven E.
AU - Brown, Jennifer R.
AU - Barrientos, Jacqueline C.
AU - Barr, Paul M.
AU - Byrd, John C.
AU - O'Brien, Susan M.
AU - Dilhuydy, Marie Sarah
AU - Hillmen, Peter
AU - Jaeger, Ulrich
AU - Moreno, Carol
AU - Cramer, Paula
AU - Stilgenbauer, Stephan
AU - Chanan-Khan, Asher A.
AU - Mahler, Michelle
AU - Salman, Mariya
AU - Eckert, Karl
AU - Solman, Isabelle G.
AU - Balasubramanian, Sriram
AU - Cheng, Mei
AU - Londhe, Anil
AU - Ninomoto, Joi
AU - Howes, Angela
AU - James, Danelle F.
AU - Hallek, Michael
N1 - Funding Information: We thank the patients who participated in these studies, their supporters, and the investigators and clinical research staff from the study centers. This report was developed with editorial support from Stacey Rose, PhD. RESONATE and RESONATE-2 were sponsored by Pharmacyclics LLC , an AbbVie Company , and HELIOS was sponsored by Janssen Research and Development . The funders were involved in the study design, data collection, analysis, and interpretation of the data for this publication. Medical writing support was funded by Pharmacyclics LLC , an AbbVie Company . Funding Information: T.J.K. reports advisory role for Pharmacyclics/advisory role for AbbVie, Genentech-Roche, Gilead, Pharmacyclics LLC, an AbbVie Company, and Celgene; research funding from AbbVie , Genentech-Roche , Pharmacyclics LLC , an AbbVie Company , and Oncternal Therapeutics . G.F. reports research funding from Janssen and Celgene ; advisory role for Pharmacyclics/advisory role for and honoraria from Janssen, AbbVie; speakers bureau for Janssen and Lundbeck. S.E.C. reports honoraria from Janssen and Pharmacyclics LLC, an AbbVie Company; advisory role for Pharmacyclics/advisory role for AbbVie, Celgene, Genentech, Pharmacyclics LLC, an AbbVie Company, Janssen, Novartis, Astellas, and AstraZeneca; research funding from AbbVie , Acerta , Celgene , Gilead , Janssen , Pharmacyclics LLC , an AbbVie Company , and Takeda ; expert testimony for Genentech; and relationship with BeiGene. J.R.B. reorts advisory role for Pharmacyclics/advisory role for AbbVie, Acerta, Astellas, BeiGene, Genentech/Roche, Gilead, Juno/Celgene, Kite, Loxo, Novartis, Pfizer, Pharmacyclics LLC, an AbbVie Company, Redx, Sun Pharma, Sunesis, TG Therapeutics, and Verastem; research funding from Gilead , Loxo , Sun Pharma , and Verastem ; honoraria from Janssen and Teva; and other relationships with MorphoSys and Invectys (data safety monitoring committees). J.C.Ba. reports honoraria from Janssen; advisory role for Pharmacyclics/advisory role for Genentech, Gilead, Bayer, Pharmacyclics LLC, an AbbVie Company, AstraZeneca, and Sandoz; research funding from Pharmacyclics LLC , an AbbVie Company , and Oncternal Therapeutics . P.M.B. reports consultancy/advisory role for Pharmacyclics LLC, an AbbVie Company, and AbbVie; research funding from Pharmacyclics LLC , an AbbVie Company . J.C.By. reports consulting/advisory role for Janssen; research funding from Pharmacyclics LLC , an AbbVie Company , Gilead , TG Therapeutics , and BeiGene ; speakers bureau with Pharmacyclics LLC, an AbbVie Company, Gilead, TG Therapeutics, Novartis, and Janssen; travel/accommodations/expenses from Pharmacyclics LLC, an AbbVie Company, Janssen, Novartis, Gilead, and TG Therapeutics. S.M.O. reports consultancy/advisory role for Amgen, Astellas, Celgene, GlaxoSmithKline, Janssen, Aptose Biosciences Inc, Vaniam Group LLC, AbbVie, Alexion, Gilead, Pharmacyclics LLC, an AbbVie Company, TG Therapeutics, Pfizer, and Sunesis; research funding from Kite , Regeneron , Acerta , Gilead , Pharmacyclics LLC , an AbbVie Company , TG Therapeutics , Pfizer , and Sunesis . M.S.D. reports consulting/advisory role for and honoraria, travel accommodations, and expenses from Janssen and AbbVie. P.H. reports consultancy/advisory role, research funding, and honoraria from Janssen, Pharmacyclics LLC, an AbbVie Company, and AbbVie; travel from AbbVie and Janssen. U.J. reports consultancy/advisory role, research funding and honoraria from Janssen. C.M. reports consultancy/advisory role for Pharmacyclics LLC, an AbbVie Company, Janssen, and AbbVie. P.C. reports consulting/advisory role for AbbVie, Acerta, AstraZeneca, Janssen-Cilag, and Roche; honoraria from AbbVie, Janssen-Cilag, and F. Hoffmann-La Roche; research funding from Acerta , Gilead , Janssen-Cilag , AbbVie , and Roche ; travel expenses from AbbVie, Janssen-Cilag, and Roche. S.S. reports consultancy/advisory role for, research funding, and honoraria from AbbVie, Amgen, Boehringer-Ingelheim, Celgene, Genentech, Genzyme, Gilead, GSK, Janssen, Mundipharma, Novartis, Pharmacyclics LLC, an AbbVie Company, and F. Hoffmann-La Roche; speakers bureau for and travel expenses from AbbVie, Janssen, and Pharmacyclics LLC, an AbbVie Company. M.M. reports equity ownership with Johnson & Johnson; employment with and travel/accommodations/expenses from Janssen Pharmaceuticals. M.S. reports employment, equity ownership, and travel accommodations with Janssen. K.E. reports employment and travel, accommodations, and expenses with Pharmacyclics LLC, an AbbVie Company; equity ownership with AbbVie. I.G.S. reports equity ownership with AbbVie; employment with and travel/accommodations/expenses with Pharmacyclics LLC, an AbbVie Company. S.B. reports employment with Janssen; equity ownership with Janssen, AbbVie, Exelixis, Vertex, and Biogen; patents/royalties/other intellectual property with Janssen and Pharmacyclics LLC, an AbbVie Company. M.C. reports employment with Pharmacyclics LLC, an AbbVie Company; equity ownership with AbbVie. A.L. reports employment and equity ownership with Johnson & Johnson. J.N. reports employment with Pharmacyclics LLC, an AbbVie Company; equity ownership with Amgen, Celgene, and AbbVie. A.H. reports employment, and leadership with Janssen; equity ownership with Johnson and Johnson. D.F.J. reports employment with and leadership role with Pharmacyclics LLC, an AbbVie Company; equity ownership (and spouse) with AbbVie; patent applications with Pharmacyclics LLC, an AbbVie Company. M.H. reports consultancy/advisory role with, speakers bureau for, and research funding with AbbVie and Roche . A.A.C.K. reports no conflict of interest. Funding Information: T.J.K. reports advisory role for Pharmacyclics/advisory role for AbbVie, Genentech-Roche, Gilead, Pharmacyclics LLC, an AbbVie Company, and Celgene; research funding from AbbVie, Genentech-Roche, Pharmacyclics LLC, an AbbVie Company, and Oncternal Therapeutics. G.F. reports research funding from Janssen and Celgene; advisory role for Pharmacyclics/advisory role for and honoraria from Janssen, AbbVie; speakers bureau for Janssen and Lundbeck. S.E.C. reports honoraria from Janssen and Pharmacyclics LLC, an AbbVie Company; advisory role for Pharmacyclics/advisory role for AbbVie, Celgene, Genentech, Pharmacyclics LLC, an AbbVie Company, Janssen, Novartis, Astellas, and AstraZeneca; research funding from AbbVie, Acerta, Celgene, Gilead, Janssen, Pharmacyclics LLC, an AbbVie Company, and Takeda; expert testimony for Genentech; and relationship with BeiGene. J.R.B. reorts advisory role for Pharmacyclics/advisory role for AbbVie, Acerta, Astellas, BeiGene, Genentech/Roche, Gilead, Juno/Celgene, Kite, Loxo, Novartis, Pfizer, Pharmacyclics LLC, an AbbVie Company, Redx, Sun Pharma, Sunesis, TG Therapeutics, and Verastem; research funding from Gilead, Loxo, Sun Pharma, and Verastem; honoraria from Janssen and Teva; and other relationships with MorphoSys and Invectys (data safety monitoring committees). J.C.Ba. reports honoraria from Janssen; advisory role for Pharmacyclics/advisory role for Genentech, Gilead, Bayer, Pharmacyclics LLC, an AbbVie Company, AstraZeneca, and Sandoz; research funding from Pharmacyclics LLC, an AbbVie Company, and Oncternal Therapeutics. P.M.B. reports consultancy/advisory role for Pharmacyclics LLC, an AbbVie Company, and AbbVie; research funding from Pharmacyclics LLC, an AbbVie Company. J.C.By. reports consulting/advisory role for Janssen; research funding from Pharmacyclics LLC, an AbbVie Company, Gilead, TG Therapeutics, and BeiGene; speakers bureau with Pharmacyclics LLC, an AbbVie Company, Gilead, TG Therapeutics, Novartis, and Janssen; travel/accommodations/expenses from Pharmacyclics LLC, an AbbVie Company, Janssen, Novartis, Gilead, and TG Therapeutics. S.M.O. reports consultancy/advisory role for Amgen, Astellas, Celgene, GlaxoSmithKline, Janssen, Aptose Biosciences Inc, Vaniam Group LLC, AbbVie, Alexion, Gilead, Pharmacyclics LLC, an AbbVie Company, TG Therapeutics, Pfizer, and Sunesis; research funding from Kite, Regeneron, Acerta, Gilead, Pharmacyclics LLC, an AbbVie Company, TG Therapeutics, Pfizer, and Sunesis. M.S.D. reports consulting/advisory role for and honoraria, travel accommodations, and expenses from Janssen and AbbVie. P.H. reports consultancy/advisory role, research funding, and honoraria from Janssen, Pharmacyclics LLC, an AbbVie Company, and AbbVie; travel from AbbVie and Janssen. U.J. reports consultancy/advisory role, research funding and honoraria from Janssen. C.M. reports consultancy/advisory role for Pharmacyclics LLC, an AbbVie Company, Janssen, and AbbVie. P.C. reports consulting/advisory role for AbbVie, Acerta, AstraZeneca, Janssen-Cilag, and Roche; honoraria from AbbVie, Janssen-Cilag, and F. Hoffmann-La Roche; research funding from Acerta, Gilead, Janssen-Cilag, AbbVie, and Roche; travel expenses from AbbVie, Janssen-Cilag, and Roche. S.S. reports consultancy/advisory role for, research funding, and honoraria from AbbVie, Amgen, Boehringer-Ingelheim, Celgene, Genentech, Genzyme, Gilead, GSK, Janssen, Mundipharma, Novartis, Pharmacyclics LLC, an AbbVie Company, and F. Hoffmann-La Roche; speakers bureau for and travel expenses from AbbVie, Janssen, and Pharmacyclics LLC, an AbbVie Company. M.M. reports equity ownership with Johnson & Johnson; employment with and travel/accommodations/expenses from Janssen Pharmaceuticals. M.S. reports employment, equity ownership, and travel accommodations with Janssen. K.E. reports employment and travel, accommodations, and expenses with Pharmacyclics LLC, an AbbVie Company; equity ownership with AbbVie. I.G.S. reports equity ownership with AbbVie; employment with and travel/accommodations/expenses with Pharmacyclics LLC, an AbbVie Company. S.B. reports employment with Janssen; equity ownership with Janssen, AbbVie, Exelixis, Vertex, and Biogen; patents/royalties/other intellectual property with Janssen and Pharmacyclics LLC, an AbbVie Company. M.C. reports employment with Pharmacyclics LLC, an AbbVie Company; equity ownership with AbbVie. A.L. reports employment and equity ownership with Johnson & Johnson. J.N. reports employment with Pharmacyclics LLC, an AbbVie Company; equity ownership with Amgen, Celgene, and AbbVie. A.H. reports employment, and leadership with Janssen; equity ownership with Johnson and Johnson. D.F.J. reports employment with and leadership role with Pharmacyclics LLC, an AbbVie Company; equity ownership (and spouse) with AbbVie; patent applications with Pharmacyclics LLC, an AbbVie Company. M.H. reports consultancy/advisory role with, speakers bureau for, and research funding with AbbVie and Roche. A.A.C.K. reports no conflict of interest.We thank the patients who participated in these studies, their supporters, and the investigators and clinical research staff from the study centers. This report was developed with editorial support from Stacey Rose, PhD. RESONATE and RESONATE-2 were sponsored by Pharmacyclics LLC, an AbbVie Company, and HELIOS was sponsored by Janssen Research and Development. The funders were involved in the study design, data collection, analysis, and interpretation of the data for this publication. Medical writing support was funded by Pharmacyclics LLC, an AbbVie Company. Publisher Copyright: © 2019 The Authors
PY - 2019/11
Y1 - 2019/11
N2 - A pooled analysis of 1238 patients with chronic lymphocytic leukemia/small lymphocytic lymphoma from three phase 3 studies found that genomic risk factors were not associated with shorter progression-free survival (PFS) or overall survival for patients treated with ibrutinib. Ibrutinib-treated patients with del(11q) were found to have a longer PFS than those without del(11q). These results suggest less prognostic relevance for certain genomic risk factors with ibrutinib treatment.
AB - A pooled analysis of 1238 patients with chronic lymphocytic leukemia/small lymphocytic lymphoma from three phase 3 studies found that genomic risk factors were not associated with shorter progression-free survival (PFS) or overall survival for patients treated with ibrutinib. Ibrutinib-treated patients with del(11q) were found to have a longer PFS than those without del(11q). These results suggest less prognostic relevance for certain genomic risk factors with ibrutinib treatment.
KW - Prognostic factors
KW - Risk factors
KW - Small lymphocytic lymphoma
KW - Survival
UR - http://www.scopus.com/inward/record.url?scp=85071099545&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85071099545&partnerID=8YFLogxK
U2 - 10.1016/j.clml.2019.07.004
DO - 10.1016/j.clml.2019.07.004
M3 - Article
C2 - 31447270
AN - SCOPUS:85071099545
SN - 2152-2650
VL - 19
SP - 715-722.e6
JO - Clinical Lymphoma, Myeloma and Leukemia
JF - Clinical Lymphoma, Myeloma and Leukemia
IS - 11
ER -