Efficacy and safety in a 4-year follow-up of the ELEVATE-TN study comparing acalabrutinib with or without obinutuzumab versus obinutuzumab plus chlorambucil in treatment-naïve chronic lymphocytic leukemia

Jeff P. Sharman; Miklos Egyed; Wojciech Jurczak; Alan Skarbnik; John M. Pagel; Ian W. Flinn; Manali Kamdar; Talha Munir; Renata Walewska; Gillian Corbett; Laura Maria Fogliatto; Yair Herishanu; Versha Banerji; Steven Coutre; George Follows; Patricia Walker; Karin Karlsson; Paolo Ghia; Ann Janssens; Florence Cymbalista; Jennifer A. Woyach; Emmanuelle Ferrant; William G. Wierda; Veerendra Munugalavadla; Ting Yu; Min Hui Wang; John C. Byrd

doi:10.1038/s41375-021-01485-x

Efficacy and safety in a 4-year follow-up of the ELEVATE-TN study comparing acalabrutinib with or without obinutuzumab versus obinutuzumab plus chlorambucil in treatment-naïve chronic lymphocytic leukemia

Jeff P. Sharman, Miklos Egyed, Wojciech Jurczak, Alan Skarbnik, John M. Pagel, Ian W. Flinn, Manali Kamdar, Talha Munir, Renata Walewska, Gillian Corbett, Laura Maria Fogliatto, Yair Herishanu, Versha Banerji, Steven Coutre, George Follows, Patricia Walker, Karin Karlsson, Paolo Ghia, Ann Janssens, Florence CymbalistaJennifer A. Woyach, Emmanuelle Ferrant, William G. Wierda, Veerendra Munugalavadla, Ting Yu, Min Hui Wang, John C. Byrd

Leukemia

Research output: Contribution to journal › Article › peer-review

85 Scopus citations

Original language	English (US)
Pages (from-to)	1171-1175
Number of pages	5
Journal	Leukemia
Volume	36
Issue number	4
DOIs	https://doi.org/10.1038/s41375-021-01485-x
State	Published - Apr 2022

ASJC Scopus subject areas

Hematology
Oncology
Cancer Research

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10.1038/s41375-021-01485-x

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Sharman, J. P., Egyed, M., Jurczak, W., Skarbnik, A., Pagel, J. M., Flinn, I. W., Kamdar, M., Munir, T., Walewska, R., Corbett, G., Fogliatto, L. M., Herishanu, Y., Banerji, V., Coutre, S., Follows, G., Walker, P., Karlsson, K., Ghia, P., Janssens, A., ... Byrd, J. C. (2022). Efficacy and safety in a 4-year follow-up of the ELEVATE-TN study comparing acalabrutinib with or without obinutuzumab versus obinutuzumab plus chlorambucil in treatment-naïve chronic lymphocytic leukemia. Leukemia, 36(4), 1171-1175. https://doi.org/10.1038/s41375-021-01485-x

Efficacy and safety in a 4-year follow-up of the ELEVATE-TN study comparing acalabrutinib with or without obinutuzumab versus obinutuzumab plus chlorambucil in treatment-naïve chronic lymphocytic leukemia. / Sharman, Jeff P.; Egyed, Miklos; Jurczak, Wojciech et al.
In: Leukemia, Vol. 36, No. 4, 04.2022, p. 1171-1175.

Research output: Contribution to journal › Article › peer-review

Sharman, JP, Egyed, M, Jurczak, W, Skarbnik, A, Pagel, JM, Flinn, IW, Kamdar, M, Munir, T, Walewska, R, Corbett, G, Fogliatto, LM, Herishanu, Y, Banerji, V, Coutre, S, Follows, G, Walker, P, Karlsson, K, Ghia, P, Janssens, A, Cymbalista, F, Woyach, JA, Ferrant, E, Wierda, WG, Munugalavadla, V, Yu, T, Wang, MH & Byrd, JC 2022, 'Efficacy and safety in a 4-year follow-up of the ELEVATE-TN study comparing acalabrutinib with or without obinutuzumab versus obinutuzumab plus chlorambucil in treatment-naïve chronic lymphocytic leukemia', Leukemia, vol. 36, no. 4, pp. 1171-1175. https://doi.org/10.1038/s41375-021-01485-x

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title = "Efficacy and safety in a 4-year follow-up of the ELEVATE-TN study comparing acalabrutinib with or without obinutuzumab versus obinutuzumab plus chlorambucil in treatment-na{\"i}ve chronic lymphocytic leukemia",

author = "Sharman, {Jeff P.} and Miklos Egyed and Wojciech Jurczak and Alan Skarbnik and Pagel, {John M.} and Flinn, {Ian W.} and Manali Kamdar and Talha Munir and Renata Walewska and Gillian Corbett and Fogliatto, {Laura Maria} and Yair Herishanu and Versha Banerji and Steven Coutre and George Follows and Patricia Walker and Karin Karlsson and Paolo Ghia and Ann Janssens and Florence Cymbalista and Woyach, {Jennifer A.} and Emmanuelle Ferrant and Wierda, {William G.} and Veerendra Munugalavadla and Ting Yu and Wang, {Min Hui} and Byrd, {John C.}",

note = "Funding Information: JS: Research funding from Seattle Genetics; research funding and consulting from AbbVie, AstraZeneca, BeiGene, BMS, Genentech, Gilead, Lilly, Pharmacyclics, TG Therapeutics; scientific board for Centessa; employment from US Oncology. ME: Nothing to disclose. WJ: Research funding from AstraZeneca, Janssen, and Loxo. AS: Consulting fees from AbbVie, AstraZeneca, Celgene, Genentech, GenMab, Kite, MorphoSys, Novartis, Pharmacyclics, Janssen, Alexion, Seattle Genetics, and TG Therapeutics; honoraria from AbbVie, AstraZeneca, BeiGene, Celgene, Genentech, Jazz Pharmaceuticals, Kite, Seattle Genetics, Pharmacyclics, Janssen, and TG Therapeutics; data safety monitoring board/advisory board participation for Alexion. JP: Consulting and speaker bureau for AstraZeneca. IF: Consulting fees from AbbVie, AstraZeneca, BeiGene, Genentech, Gilead, Great Point Partners, Iksuda, Janssen, Juno, Kite, MorphoSys, Nurix, Pharmacyclics, Roche, Seattle Genetics, Takeda, TG Therapeutics, Unum, Verastem, and Yingli; grants from AbbVie, Acerta, Agios, ArQule, AstraZeneca, BeiGene, Calithera, Celgene, Constellation, Curis, Forma, Forty Seven, Genentech, Gilead, IGM Biosciences, Incyte, Infinity, Janssen, Juno, Karyopharm, Kite, Loxo, Merck, MorphoSys, Novartis, Pfizer, Pharmacyclics, Portola, Rhizen, Roche, Seattle Genetics, Takeda, Teva, TG Therapeutics, Trilium, Triphase, Unum, and Verastem. MK: Research support/funding from TG Therapeutics and Genentech; consulting for AbbVie, Karyopharm, Kite, AstraZeneca, Celgene/Bristol Myers Squibb, Adaptive, and ADC Therapeutics; speaker{\textquoteright}s bureau for Seagen; data monitoring committee member for Celgene and Genentech. TM: Consulting/advisory role for Morphosys, Sunesis, AstraZeneca, Janssen; honoraria from Janssen, AstraZeneca, Gilead, and Novartis. RW: Nothing to disclose. GC: Nothing to disclose. LMF: Nothing to disclose. YH: Honoraria from AbbVie, Janssen, AstraZeneca, and Roche. VB: Honoraria from AbbVie, Janssen, and AstraZeneca; grant funding from the Canadian Institutes of Health Research, Leukemia Lymphoma Society of Canada, CancerCare Manitoba Foundation, and the Hairy Cell Leukemia Foundation. SC: Honoraria from Janssen Oncology and Pharmacyclics; consulting for AbbVie, Adaptive Biotechnologies, AstraZeneca, BeiGene, Genentech/Roche, Janssen Oncology, and Pharmacyclics; clinical research support from AbbVie, Acerta Pharma/AstraZeneca, Janssen Oncology, Pharmacyclics; expert testimony for Genentech. GF: Consulting fees from AstraZeneca, Roche, AbbVie, Janssen, Karyopharm, Bristol Myers Squibb, and Centessa; honoraria from AstraZeneca, Roche, AbbVie, and Janssen; travel support from Roche, Janssen, and Bristol Myers Squibb. PW: Travel support from Roche; honoraria from AstraZeneca. KK: Nothing to disclose. PG: Honoraria from AbbVie, AstraZeneca, ArQule/MSD, BeiGene, Janssen, Loxo/Lilly, and Roche; research support from AbbVie, AstraZeneca, Janssen, and Sunesis. AJ: Consulting fees from Janssen, Roche, Gilead, AbbVie, Novartis, Amgen, Sanofi-Genzyme, and AstraZeneca; honoraria from Janssen, Roche, AbbVie, Novartis, Amgen, AstraZeneca, and BeiGene; travel support from AbbVie, Roche, Amgen, and Bristol Myers Squibb/Celgene. FC: Consulting fees from AbbVie; honoraria from Roche, AbbVie, AstraZeneca, and Janssen; travel support from AstraZeneca, Roche, and AbbVie. JW: Consulting for AbbVie, Janssen, Pharmacyclics, BeiGene, AstraZeneca, ArQule, and Loxo; research support from Loxo and AbbVie; clinical trial support from Karyopharm, Morphosys, Pharmacyclics, and Janssen. EF: Honoraria from Janssen-Cilag; payment for expert testimony from Gilead, AbbVie, and Janssen-Cilag. WW: Grants/ contracts from GSK/Novartis, AbbVie, Genentech, Pharmacyclics, AstraZeneca/Acerta, Gilead, Juno, Kite, Sunesis, Miragen, Oncternal, Cyclacel, Loxo, Janssen, and Xencor. VM: Stock from and employment by AstraZeneca; family member association with Gilead. TY: Employment by AstraZeneca; stock from AstraZeneca, Johnson & Johnson, and AbbVie. MHW: Stock from and employment by AstraZeneca. JB: Stock and other ownership interests from Vincerx; honoraria from Pharmacyclics, AstraZeneca, Novartis, Syndax, and Trillium; consulting or advisory role for Acerta, Janssen, Kura, Novartis, Syndax, and AstraZeneca; research funding from Acerta, Pharmacyclics, and Zencor; patents, royalties, and other intellectual property from OSU Patents; travel support from Gilead, Janssen, Novartis, Pharmacyclics, and TG Therapeutics. Funding Information: The authors are grateful for the contributions of our co-author, colleague, and friend Dr. Steven Coutre, who sadly passed away just before publication of this report; he will be dearly missed. The study was funded by Acerta Pharma, South San Francisco, CA, a member of the AstraZeneca Group. Medical writing assistance, funded by AstraZeneca, was provided by Tracy Diaz, PhD, and Cindy Gobbel, PhD, of Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ.",

year = "2022",

month = apr,

doi = "10.1038/s41375-021-01485-x",

language = "English (US)",

volume = "36",

pages = "1171--1175",

journal = "Leukemia",

issn = "0887-6924",

publisher = "Nature Publishing Group",

number = "4",

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TY - JOUR

T1 - Efficacy and safety in a 4-year follow-up of the ELEVATE-TN study comparing acalabrutinib with or without obinutuzumab versus obinutuzumab plus chlorambucil in treatment-naïve chronic lymphocytic leukemia

AU - Sharman, Jeff P.

AU - Egyed, Miklos

AU - Jurczak, Wojciech

AU - Skarbnik, Alan

AU - Pagel, John M.

AU - Flinn, Ian W.

AU - Kamdar, Manali

AU - Munir, Talha

AU - Walewska, Renata

AU - Corbett, Gillian

AU - Fogliatto, Laura Maria

AU - Herishanu, Yair

AU - Banerji, Versha

AU - Coutre, Steven

AU - Follows, George

AU - Walker, Patricia

AU - Karlsson, Karin

AU - Ghia, Paolo

AU - Janssens, Ann

AU - Cymbalista, Florence

AU - Woyach, Jennifer A.

AU - Ferrant, Emmanuelle

AU - Wierda, William G.

AU - Munugalavadla, Veerendra

AU - Yu, Ting

AU - Wang, Min Hui

AU - Byrd, John C.

N1 - Funding Information: JS: Research funding from Seattle Genetics; research funding and consulting from AbbVie, AstraZeneca, BeiGene, BMS, Genentech, Gilead, Lilly, Pharmacyclics, TG Therapeutics; scientific board for Centessa; employment from US Oncology. ME: Nothing to disclose. WJ: Research funding from AstraZeneca, Janssen, and Loxo. AS: Consulting fees from AbbVie, AstraZeneca, Celgene, Genentech, GenMab, Kite, MorphoSys, Novartis, Pharmacyclics, Janssen, Alexion, Seattle Genetics, and TG Therapeutics; honoraria from AbbVie, AstraZeneca, BeiGene, Celgene, Genentech, Jazz Pharmaceuticals, Kite, Seattle Genetics, Pharmacyclics, Janssen, and TG Therapeutics; data safety monitoring board/advisory board participation for Alexion. JP: Consulting and speaker bureau for AstraZeneca. IF: Consulting fees from AbbVie, AstraZeneca, BeiGene, Genentech, Gilead, Great Point Partners, Iksuda, Janssen, Juno, Kite, MorphoSys, Nurix, Pharmacyclics, Roche, Seattle Genetics, Takeda, TG Therapeutics, Unum, Verastem, and Yingli; grants from AbbVie, Acerta, Agios, ArQule, AstraZeneca, BeiGene, Calithera, Celgene, Constellation, Curis, Forma, Forty Seven, Genentech, Gilead, IGM Biosciences, Incyte, Infinity, Janssen, Juno, Karyopharm, Kite, Loxo, Merck, MorphoSys, Novartis, Pfizer, Pharmacyclics, Portola, Rhizen, Roche, Seattle Genetics, Takeda, Teva, TG Therapeutics, Trilium, Triphase, Unum, and Verastem. MK: Research support/funding from TG Therapeutics and Genentech; consulting for AbbVie, Karyopharm, Kite, AstraZeneca, Celgene/Bristol Myers Squibb, Adaptive, and ADC Therapeutics; speaker’s bureau for Seagen; data monitoring committee member for Celgene and Genentech. TM: Consulting/advisory role for Morphosys, Sunesis, AstraZeneca, Janssen; honoraria from Janssen, AstraZeneca, Gilead, and Novartis. RW: Nothing to disclose. GC: Nothing to disclose. LMF: Nothing to disclose. YH: Honoraria from AbbVie, Janssen, AstraZeneca, and Roche. VB: Honoraria from AbbVie, Janssen, and AstraZeneca; grant funding from the Canadian Institutes of Health Research, Leukemia Lymphoma Society of Canada, CancerCare Manitoba Foundation, and the Hairy Cell Leukemia Foundation. SC: Honoraria from Janssen Oncology and Pharmacyclics; consulting for AbbVie, Adaptive Biotechnologies, AstraZeneca, BeiGene, Genentech/Roche, Janssen Oncology, and Pharmacyclics; clinical research support from AbbVie, Acerta Pharma/AstraZeneca, Janssen Oncology, Pharmacyclics; expert testimony for Genentech. GF: Consulting fees from AstraZeneca, Roche, AbbVie, Janssen, Karyopharm, Bristol Myers Squibb, and Centessa; honoraria from AstraZeneca, Roche, AbbVie, and Janssen; travel support from Roche, Janssen, and Bristol Myers Squibb. PW: Travel support from Roche; honoraria from AstraZeneca. KK: Nothing to disclose. PG: Honoraria from AbbVie, AstraZeneca, ArQule/MSD, BeiGene, Janssen, Loxo/Lilly, and Roche; research support from AbbVie, AstraZeneca, Janssen, and Sunesis. AJ: Consulting fees from Janssen, Roche, Gilead, AbbVie, Novartis, Amgen, Sanofi-Genzyme, and AstraZeneca; honoraria from Janssen, Roche, AbbVie, Novartis, Amgen, AstraZeneca, and BeiGene; travel support from AbbVie, Roche, Amgen, and Bristol Myers Squibb/Celgene. FC: Consulting fees from AbbVie; honoraria from Roche, AbbVie, AstraZeneca, and Janssen; travel support from AstraZeneca, Roche, and AbbVie. JW: Consulting for AbbVie, Janssen, Pharmacyclics, BeiGene, AstraZeneca, ArQule, and Loxo; research support from Loxo and AbbVie; clinical trial support from Karyopharm, Morphosys, Pharmacyclics, and Janssen. EF: Honoraria from Janssen-Cilag; payment for expert testimony from Gilead, AbbVie, and Janssen-Cilag. WW: Grants/ contracts from GSK/Novartis, AbbVie, Genentech, Pharmacyclics, AstraZeneca/Acerta, Gilead, Juno, Kite, Sunesis, Miragen, Oncternal, Cyclacel, Loxo, Janssen, and Xencor. VM: Stock from and employment by AstraZeneca; family member association with Gilead. TY: Employment by AstraZeneca; stock from AstraZeneca, Johnson & Johnson, and AbbVie. MHW: Stock from and employment by AstraZeneca. JB: Stock and other ownership interests from Vincerx; honoraria from Pharmacyclics, AstraZeneca, Novartis, Syndax, and Trillium; consulting or advisory role for Acerta, Janssen, Kura, Novartis, Syndax, and AstraZeneca; research funding from Acerta, Pharmacyclics, and Zencor; patents, royalties, and other intellectual property from OSU Patents; travel support from Gilead, Janssen, Novartis, Pharmacyclics, and TG Therapeutics. Funding Information: The authors are grateful for the contributions of our co-author, colleague, and friend Dr. Steven Coutre, who sadly passed away just before publication of this report; he will be dearly missed. The study was funded by Acerta Pharma, South San Francisco, CA, a member of the AstraZeneca Group. Medical writing assistance, funded by AstraZeneca, was provided by Tracy Diaz, PhD, and Cindy Gobbel, PhD, of Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ.

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Efficacy and safety in a 4-year follow-up of the ELEVATE-TN study comparing acalabrutinib with or without obinutuzumab versus obinutuzumab plus chlorambucil in treatment-naïve chronic lymphocytic leukemia

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