Ibrutinib Regimens versus Chemoimmunotherapy in Older Patients with Untreated CLL
Jennifer A. Woyach,Amy S. Ruppert,Nyla A. Heerema,Weiqiang Zhao,Allison M Booth,Wei Ding,Nancy L. Bartlett,Danielle M. Brander,Paul M. Barr,Kerry A. Rogers,Sameer A. Parikh,Steven Coutre,Arti Hurria,Jennifer R. Brown,Gerard Lozanski,James S. Blachly,Hatice Gulcin Ozer,Brittny Major-Elechi,Briant Fruth,Sreenivasa Nattam,Richard A. Larson,Harry P. Erba,Mark R. Litzow,Carolyn Owen,Charles S. Kuzma,Jeremy S. Abramson,Richard F. Little,Scott E. Smith,Richard Stone,Sumithra J. Mandrekar,John C. Byrd +30 more
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TLDR
Among older patients with untreated CLL, treatment with ibrutinib was superior to treatment with bendamustine plus rituximab with regard to progression‐free survival, and there was no significant difference among the three treatment groups with respect to overall survival.Abstract:
Background Ibrutinib has been approved by the Food and Drug Administration for the treatment of patients with untreated chronic lymphocytic leukemia (CLL) since 2016 but has not been compared with chemoimmunotherapy. We conducted a phase 3 trial to evaluate the efficacy of ibrutinib, either alone or in combination with rituximab, relative to chemoimmunotherapy. Methods Patients 65 years of age or older who had untreated CLL were randomly assigned to receive bendamustine plus rituximab, ibrutinib, or ibrutinib plus rituximab. The primary end point was progression-free survival. The Alliance Data and Safety Monitoring Board made the decision to release the data after the protocol-specified efficacy threshold had been met. Results A total of 183 patients were assigned to receive bendamustine plus rituximab, 182 to receive ibrutinib, and 182 to receive ibrutinib plus rituximab. Median progression-free survival was reached only with bendamustine plus rituximab. The estimated percentage of patients wit...read more
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Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions
Kirsten Fischer,Othman Al-Sawaf,Jasmin Bahlo,Anna-Maria Fink,Maneesh Tandon,Mark Dixon,Sandra Robrecht,Simon Warburton,Kathryn Humphrey,Olga Samoylova,Anna M. Liberati,Javier Pinilla-Ibarz,Stephen Opat,Liliya Sivcheva,Katell Le Du,Laura M. Fogliatto,Carsten Utoft Niemann,Robert Weinkove,Sue Robinson,Thomas J. Kipps,Sebastian Boettcher,Eugen Tausch,Rod A. Humerickhouse,Barbara Eichhorst,Clemens M. Wendtner,Anton W. Langerak,Karl Anton Kreuzer,Matthias Ritgen,Valentin Goede,Stephan Stilgenbauer,Mehrdad Mobasher,Michael Hallek +31 more
TL;DR: Among patients with untreated CLL and coexisting conditions, venetoclax-obinutuzumab was associated with longer progression-free survival than chlorambucil-obinutsumab and this benefit was also observed in patients with TP53 deletion, mutation, or both and in Patients with unmutated immunoglobulin heavy-chain genes.
Journal ArticleDOI
Ibrutinib–Rituximab or Chemoimmunotherapy for Chronic Lymphocytic Leukemia
Tait D. Shanafelt,Xin V. Wang,Neil E. Kay,Curtis A. Hanson,Susan O'Brien,Jacqueline C. Barrientos,Diane F. Jelinek,Esteban Braggio,Jose F. Leis,Cong C. Zhang,Steven Coutre,Paul M. Barr,Amanda F. Cashen,Anthony R. Mato,Avina K. Singh,Michael P Mullane,Richard F. Little,Harry P. Erba,Richard Stone,Mark R. Litzow,Martin S. Tallman +20 more
TL;DR: The ibrutinib-rituximab regimen resulted in progression-free survival and overall survival that were superior to those with a standard chemoimmunotherapy regimen among patients 70 years of age or younger with previously untreated CLL.
Journal ArticleDOI
Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial
Jeff P. Sharman,Miklos Egyed,Wojciech Jurczak,Alan P Skarbnik,Alan P Skarbnik,John M. Pagel,Ian W. Flinn,Manali Kamdar,Talha Munir,Renata Walewska,Gillian Corbett,Laura Fogliatto,Yair Herishanu,Versha Banerji,Steven Coutre,George A Follows,Patricia F. Walker,Karin Karlsson,Paolo Ghia,Ann Janssens,Florence Cymbalista,Jennifer A. Woyach,Gilles Salles,William G. Wierda,Raquel Izumi,Veerendra Munugalavadla,Priti Patel,Min Hui Wang,Sofia Wong,John C. Byrd +29 more
TL;DR: The primary endpoint was progression-free survival between the two combination-therapy groups, assessed by independent review committee.
Journal ArticleDOI
Chronic lymphocytic leukemia: 2020 update on diagnosis, risk stratification and treatment
TL;DR: Chronic lymphocytic leukemia (CLL), the commonest leukemia in western countries, typically occurs in elderly patients and has a highly variable clinical course.
Journal ArticleDOI
Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study
Jan A. Burger,Paul M. Barr,Tadeusz Robak,Carolyn Owen,Paolo Ghia,Alessandra Tedeschi,Osnat Bairey,Peter Hillmen,Steven Coutre,Stephen Devereux,Sebastian Grosicki,Helen McCarthy,David Simpson,Fritz Offner,Carol Moreno,Sandra Dai,Indu Lal,James P. Dean,Thomas J. Kipps +18 more
TL;DR: Ibrutinib benefit was consistent in patients with high prognostic risk ( TP53 mutation, 11q deletion, and/or unmutated IGHV ) and increased depth of response over time and sustained PFS and OS benefit versus chlorambucil.
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