`
`Ibrutinib dons new anti-GVHD hat | MDedge Hematology and Oncology
`
`AT EHA 2017
`
`MADRID – Talk about versatility: Ibrutinib (Imbruvica), a drug with marked activity against B-cell
`malignancies, also appears to be a safe and acceptable option for the treatment of patients with
`chronic graft vs. host disease (cGVHD) for whom frontline therapies have failed.
`
`Among 42 patients in a phase II study with steroid-refractory cGVHD, the overall response rate
`with ibrutinib was 67%, with one-third of responders having a complete response, reported Iskra
`Pusic, MD, from Washington University School of Medicine in St. Louis.
`
`Neil Osterweil/Frontline Medical News
`Dr. Iskra Pusic
`
`“Ibrutinib resulted in clinically meaningful and sustained responses in patients who have failed at
`least one prior treatment. They were able to taper steroids, and it’s important to underline here
`that we saw responses even in the setting of tapering steroids,” she said at a briefing at the annual
`congress of the European Hematology Association.
`Corticosteroids are the most commonly used therapy for cGVHD in the United States, but for those
`patients for whom corticosteroids are a bust, there is no established second-line therapy, and
`patients with refractory cGVHD are usually recommended for clinical trials, Dr. Pusic said.
`
`The therapeutic rationale underpinning the use of ibrutinib in cGVHD, a condition marked by
`extensive immune dysregulation, is that the agent is an irreversible inhibitor of Bruton’s tyrosine
`kinase and interleukin-2 inducible T-cell kinase, and thus has wide-ranging immune-dampening
`activity, Dr. Pusic said.
`
`https://www.mdedge.com/hematology-oncology/article/141170/patient-survivor-care/ibrutinib-dons-new-anti-gvhd-hat
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`CONFERENCE COVERAGE
`Ibrutinib dons new anti-GVHD hat
`Publish date: June 24, 2017
`By Neil Osterweil
`
`
`Ibrutinib dons new anti-GVHD hat | MDedge Hematology and Oncology
`11/25/2019
`She and colleagues in a multicenter study enrolled 42 patients with cGVHD that corticosteroids
`had failed to treat adequately, and treated them with oral ibrutinib 420 mg daily until cGVHD
`progression or unacceptable toxicity.
`
`At a median follow-up of 13.9 months, a total of 28 patients (67%) had a response according to
`2005 National Institutes of Health (NIH) criteria, including nine with a complete response, and 19
`with partial responses.
`
`Of the patients with responses, 79% had a response at the time of the first assessment for response,
`and 71% of responders had responses lasting at least 5 months.
`
`Among patients with multiorgan involvement, responses were seen in two or more organs.
`
`Grade 3 or greater adverse events included fatigue, diarrhea, muscles spasms, pneumonia, pyrexia,
`and headache. Two patients died on study, one from multilobular pneumonia and one from
`bronchopulmonary aspergillosis.
`
`In general, the safety profile of ibrutinib was similar to that seen in studies of the drug in B-cell
`malignancies and to that seen with corticosteroid therapy for patients with cGVHD, Dr. Pusic said.
`
`Investigators are currently enrolling patients in a double-blind clinical trial comparing ibrutinib or
`placebo in combination with corticosteroids in patients with newly diagnosed cGVHD, she noted.
`
`The study was supported by Pharmacyclics. Dr. Pusic did not report disclosures.
`
`Copyright © 2019 Frontline Medical Communications Inc., Parsippany, NJ, USA. All rights reserved.
`Unauthorized use prohibited. The information provided is for educational purposes only. Use of this Web site
`is subject to the medical disclaimer and privacy policy.
`
`https://www.mdedge.com/hematology-oncology/article/141170/patient-survivor-care/ibrutinib-dons-new-anti-gvhd-hat
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