Matching-adjusted indirect comparisons of safety and efficacy of acalabrutinib versus other targeted therapies in patients with treatment-naive chronic lymphocytic leukemia

被引：10

作者：

Davids, Matthew S. ^{[1
]}

Telford, Claire ^{[2
]}

Abhyankar, Sarang ^{[2
]}

Waweru, Catherine ^{[2
]}

Ringshausen, Ingo ^{[3
]}

机构：

[1] Dana Farber Canc Inst, Dept Med Oncol, Boston, MA 02115 USA

[2] AstraZeneca, Gaithersburg, MD 20878 USA

[3] Univ Cambridge, Dept Haematol, Cambridge, England

来源：

LEUKEMIA & LYMPHOMA | 2021年 / 62卷 / 10期

关键词：

Acalabrutinib; Bruton tyrosine kinase inhibitor; chronic lymphocytic leukemia; matching-adjusted indirect comparison; targeted therapy; PLUS CHLORAMBUCIL; ELEVATE TN; OBINUTUZUMAB; PHASE-3;

D O I：

10.1080/10428194.2021.1913144

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Acalabrutinib is a highly selective, potent, next-generation, covalent Bruton tyrosine kinase inhibitor with minimal off-target activity. Matching-adjusted indirect comparisons (MAICs) were performed to estimate the safety and efficacy of acalabrutinib compared to other targeted therapies for treatment-naive patients with chronic lymphocytic leukemia (CLL). Individual patient data for acalabrutinib (ELEVATE-TN trial) were matched to aggregate baseline characteristics for comparators. After matching, acalabrutinib (with or without obinutuzumab) showed improved safety outcomes, except for increased risk of neutropenia (p < 0.001) for acalabrutinib plus obinutuzumab versus ibrutinib and increased risk of leukopenia (p < 0.05) for acalabrutinib (with or without obinutuzumab) versus venetoclax plus obinutuzumab. There was no statistically significant difference in progression-free survival between acalabrutinib (with or without obinutuzumab) and any of the comparators. This MAIC demonstrated a favorable safety profile for acalabrutinib-based therapy compared with other targeted therapies in treatment-naive patients with CLL, without compromising efficacy.

引用

页码：2342 / 2351

页数：10

共 31 条

[1] Sustained efficacy and detailed clinical follow-up of first-line ibrutinib treatment in older patients with chronic lymphocytic leukemia: extended phase 3 results from RESONATE-2 [J].

Barr, Paul M. ;

Robak, Tadeusz ;

Owen, Carolyn ;

Tedeschi, Alessandra ;

Bairey, Osnat ;

Bartlett, Nancy L. ;

Burger, Jan A. ;

Hillmen, Peter ;

Coutre, Steven ;

Devereux, Stephen ;

Grosicki, Sebastian ;

McCarthy, Helen ;

Li, Jianyong ;

Simpson, David ;

Offner, Fritz ;

Moreno, Carol ;

Zhou, Cathy ;

Styles, Lori ;

James, Danelle ;

Kipps, Thomas J. ;

Ghia, Paolo .

HAEMATOLOGICA, 2018, 103 (09) :1502-1510

[2] Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia [J].

Burger, J. A. ;

Tedeschi, A. ;

Barr, P. M. ;

Robak, T. ;

Owen, C. ;

Ghia, P. ;

Bairey, O. ;

Hillmen, P. ;

Bartlett, N. L. ;

Li, J. ;

Simpson, D. ;

Grosicki, S. ;

Devereux, S. ;

McCarthy, H. ;

Coutre, S. ;

Quach, H. ;

Gaidano, G. ;

Maslyak, Z. ;

Stevens, D. A. ;

Janssens, A. ;

Offner, F. ;

Mayer, J. ;

O'Dwyer, M. ;

Hellmann, A. ;

Schuh, A. ;

Siddiqi, T. ;

Polliack, A. ;

Tam, C. S. ;

Suri, D. ;

Cheng, M. ;

Clow, F. ;

Styles, L. ;

James, D. F. ;

Kipps, T. J. ;

Keating, Michael ;

Jen, Jie ;

Jindra, Pavel ;

Simkovic, Martin ;

Braester, Andrei ;

Ruchlemer, Rosa ;

Foa, Roberto ;

Semenzato, Gianpietro ;

Hawkins, Timothy ;

Atanasio, Carolina Moreno ;

Demirkan, Fatih ;

Kaynar, Leylagul ;

Pylypenko, Halyna ;

Fox, Christopher ;

Thirman, Michael ;

Campbell, Philip .

NEW ENGLAND JOURNAL OF MEDICINE, 2015, 373 (25) :2425-2437

[3] Comparative Efficacy of Acalabrutinib in Frontline Treatment of Chronic Lymphocytic Leukemia: A Systematic Review and Network Meta-analysis [J].

Davids, Matthew S. ;

Waweru, Catherine ;

Le Nouveau, Pauline ;

Padhiar, Amie ;

Singh, Gautamjeet ;

Abhyankar, Sarang ;

Leblond, Veronique .

CLINICAL THERAPEUTICS, 2020, 42 (10) :1955-U46

[4] Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-upaEuro [J].

Eichhorst, B. ;

Robak, T. ;

Montserrat, E. ;

Ghia, P. ;

Hillmen, P. ;

Hallek, M. ;

Buske, C. .

ANNALS OF ONCOLOGY, 2015, 26 :V78-V84

[5]

EMA, CALQUENCE SUMMARY PR

[6]

ESMO, 2017, EUROPEAN SOC MEDICAL

[7] Obinutuzumab plus Chlorambucil in Patients with CLL and Coexisting Conditions [J].

Goede, Valentin ;

Fischer, Kirsten ;

Busch, Raymonde ;

Engelke, Anja ;

Eichhorst, Barbara ;

Wendtner, Clemens M. ;

Chagorova, Tatiana ;

de la Serna, Javier ;

Dilhuydy, Marie-Sarah ;

Illmer, Thomas ;

Opat, Stephen ;

Owen, Carolyn J. ;

Samoylova, Olga ;

Kreuzer, Karl-Anton ;

Stilgenbauer, Stephan ;

Doehner, Hartmut ;

Langerak, Anton W. ;

Ritgen, Matthias ;

Kneba, Michael ;

Asikanius, Elina ;

Humphrey, Kathryn ;

Wenger, Michael ;

Hallek, Michael .

NEW ENGLAND JOURNAL OF MEDICINE, 2014, 370 (12) :1101-1110

[8] The specific Bruton tyrosine kinase inhibitor acalabrutinib (ACP-196) shows favorable in vitro activity against chronic lymphocytic leukemia B cells with CD20 antibodies [J].

Golay, Josee ;

Ubiali, Greta ;

Introna, Martino .

HAEMATOLOGICA, 2017, 102 (10) :E400-E403

[9] Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves [J].

Guyot, Patricia ;

Ades, A. E. ;

Ouwens, Mario J. N. M. ;

Welton, Nicky J. .

BMC MEDICAL RESEARCH METHODOLOGY, 2012, 12

[10] Chronic lymphocytic leukaemia [J].

Hallek, Michael ;

Shanafelt, Tait D. ;

Eichhorst, Barbara .

LANCET, 2018, 391 (10129) :1524-1537

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