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Blood. 2015 Aug 6;126(6):739-45. doi: 10.1182/blood-2015-03-635326. Epub 2015 Jun 9.

Long-term follow-up of MCL patients treated with single-agent ibrutinib: updated safety and efficacy results.

Author information

  • 1The University of Texas MD Anderson Cancer Center, Houston, TX;
  • 2Ohio State University Comprehensive Cancer Center, Columbus, OH;
  • 3Weill Cornell Medical College, New York, NY;
  • 4John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, NJ;
  • 5Barts Health National Health Service (NHS) Trust, London, United Kingdom;
  • 6University of Wisconsin School of Medicine and Public Health, Madison, WI;
  • 7Jagiellonian University, Krakow, Poland;
  • 8Stanford University Medical Center, Stanford, CA;
  • 9University of Virginia School of Medicine, Charlottesville, VA;
  • 10Hofstra North Shore-Long Island Jewish School of Medicine, Hempstead, NY;
  • 11Oddzial Kliniczny Onkologii, Centrum Onkologii, Bydgoszcz, Poland;
  • 12The University of Manchester and the Christie NHS Foundation Trust, Manchester, United Kingdom;
  • 13Universitatsklinikum Ulm, Klinik fur Innere Medizin II, Ulm, Germany;
  • 14University Hospital LMU Munich, Germany;
  • 15Medical University of Warsaw, Warsaw, Poland;
  • 16Cancer Research UK Clinical Centre, Southampton General Hospital, Southampton, United Kingdom;
  • 17Oregon Health and Science University, Portland, OR;
  • 18Pharmacyclics LLC, Sunnyvale, CA; and.
  • 19Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, United Kingdom.


Ibrutinib, an oral inhibitor of Bruton tyrosine kinase, is approved for patients with mantle cell lymphoma (MCL) who have received one prior therapy. We report the updated safety and efficacy results from the multicenter, open-label phase 2 registration trial of ibrutinib (median 26.7-month follow-up). Patients (N = 111) received oral ibrutinib 560 mg once daily, and those with stable disease or better could enter a long-term extension study. The primary end point was overall response rate (ORR). The median patient age was 68 years (range, 40-84), with a median of 3 prior therapies (range, 1-5). The median treatment duration was 8.3 months; 46% of patients were treated for >12 months, and 22% were treated for ≥2 years. The ORR was 67% (23% complete response), with a median duration of response of 17.5 months. The 24-month progression-free survival and overall survival rates were 31% (95% confidence interval [CI], 22.3-40.4) and 47% (95% CI, 37.1-56.9), respectively. The most common adverse events (AEs) in >30% of patients included diarrhea (54%), fatigue (50%), nausea (33%), and dyspnea (32%). The most frequent grade ≥3 infections included pneumonia (8%), urinary tract infection (4%), and cellulitis (3%). Grade ≥3 bleeding events in ≥2% of patients were hematuria (2%) and subdural hematoma (2%). Common all-grade hematologic AEs were thrombocytopenia (22%), neutropenia (19%), and anemia (18%). The prevalence of infection, diarrhea, and bleeding was highest for the first 6 months of therapy and less thereafter. With longer follow-up, ibrutinib continues to demonstrate durable responses and favorable safety in relapsed/refractory MCL. The trial is registered to as #NCT01236391.

© 2015 by The American Society of Hematology.

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