■ HEMATOLOGY/ONCOLOGY ■ BONE MARROW TRANSPLANTATION
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`Hematolog y/Oncology
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`Bone Marrow Transplantation
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`COVERSmRY
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`GVHD management improves, but
`questions remain about risk stratification,
`prophylaxis
`
`Hem:::lnc Today , June 10, 2018
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`The FDA approval of ibrutinib for adults with chronic graft-versus-host disease may herald
`a practice-changing breakthrough in the management of this posttransplant complication.
`
`GVHD causes a cross-section of complications -
`from infections to debilitating tissue
`injury that can cause irreversible fibrosis -
`that have made it a daunting challenge
`following hematopoietic stem cell transplant. Although the approval of one drug will not
`eliminate all these challenges, there is hope the agent will provide a step on the road to
`long-term GVHD management.
`
`"For a long time, there were no new drugs for GVHD , at least in part because
`pharmaceutical companies were reluctant to get involved ," James L.M. Ferrara MD,
`DSc, Ward-Coleman chair in cancer medicine ; director of Hematologic Malignancies
`Translational Research Center at Tisch Cancer Institute; and professor of medicine,
`hematology and medical oncology at Icahn School of Medicine at Mount Sinai, told
`Hem One Today. "One very smart senior VP of a pharma company said the problem is
`that GVHD is where new drugs go to die."
`
`Still, the tide may be changing with increased understanding of GVHD biology, and with
`encouraging data emerging on JAK and histone deacetylase inhibitors.
`
`"However, there are a couple of big questions that we'll need to answer with these drugs,"
`Ferrara said. "One is whether we'll be able to get a complete response , and another is
`whether we' II be able to get patients off steroids, which decimate the immune system."
`
`Beyond treatment, researchers also are working to prevent GVHD by identifying novel
`biomarkers for stratifying patients. The gut microbiome and donor type and source are
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`other areas of active investigation.
`
`Hem One Today spoke with HSCT experts about the long-term complications associated
`with GVHD , the impact of the ibrutinib (lmbruvica; Pharmacyclics, Janssen) approval,
`ongoing research to better understand and treat acute and chronic GVHD , and headway
`being made into GVHD prophylaxis.
`
`Impact of GVHD
`
`Although HSCT can provide long-term survival for some patients with hematologic
`malignancies , the procedure poses a substantial risk for GVHD .
`
`Following allogeneic HSCT, GVHD develops when the donor's immune cells attack the
`patient's normal cells.
`
`Acute GVHD - which typically occurs soon after transplant- can range from mild to
`severe , and can be life-threatening if not controlled.
`
`Chronic GVHD can occur 3 months to up to 2 years after transplant. Although chronic
`GVHD is more common among patients who experienced acute GVHD , patients can
`experience both, either or neither type of GVHD.
`
`Incidence of acute GVHD ranges from 26% to 50% among recipients of matched sibling
`donor grafts, and from 42% to 75% among recipients of matched unrelated donor grafts.
`Chronic GVHD can affect around 30% of recipients of fully matched transplants to 60% to
`70% of recipients of mismatched transplants.
`
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