This article is more than 5 years old. Information may no longer be current.
VIDEO: Ibrutinib could be ‘game changer’ for GVHD treatment
Click Here to Manage Email Alerts
SAN DIEGO — Ibrutinib safely and effectively treated patients with chronic graft-versus-host disease who failed at least one line of systemic therapy, according to a late-breaking abstract presented at the ASH Annual Meeting and Exposition.
Early results of the multicenter, open-label phase 2 study supported the FDA’s decision to grant breakthrough therapy designation to ibrutinib (Imbruvica; Pharmacyclics, Janssen) for this indication.
“We are anxious to see what the FDA thinks of this data in their final package assessments early in 2017,” David Miklos, MD, associate professor of medicine at Stanford University, told HemOnc Today. “It could be a game changer for patients who, at this point, have no approved therapies.”
Miklos and colleagues evaluated 420-mg daily doses of ibrutinib in patients who developed chronic graft-versus-host disease (GVHD) after allogeneic stem cell transplantation and failed corticosteroids. Treatment continued until chronic GVHD progression or unacceptable toxicity.
After median follow-up of 13.9 months, researchers reported a 67% overall response rate. Seventy-one percent of responders achieved sustained response of 20 weeks or more, and 48% of responders achieved a sustained response for at least 32 weeks. – by Kristie L. Kahl
Reference:
Miklos D, et al. Abstract LBA-3. Presented at: ASH Annual Meeting and Exposition; Dec. 3-6, 2016; San Diego.
Disclosure: Miklos reports a consultant role with Pharmacyclics; travel and accommodations from Pharmacyclics and Sanofi; and research funding from Kite Pharma, Novartis, Pharmacyclics and Roche.