publication date: Dec. 22, 2016

Hematologic Malignancies Imbruvica Shows Response in 2/3 of Steroid Dependent, Refractory cGVHD Patients in Phase II Study

In a phase II study, ibrutinib (Imbruvica) demonstrated clinically meaningful and durable responses and reduced symptom severity, with an overall response rate of 67% in patients with cGVHD.

The data were presented at the 58th American Society of Hematology Annual Meeting in San Diego.

Imbruvica, a first-in-class Bruton’s tyrosine kinase inhibitor, is jointly developed and commercialized by Janssen Biotech Inc. and Pharmacyclics LLC, an AbbVie company.

At a median follow-up of 14 months (0.5-25) in 42 patients, one third of all responders achieved a complete response; 71% of patients with a complete or partial response showed a sustained response of at least 5 months.

Over the course of the study, 61% of responders experienced a clinically meaningful improvement in symptoms, as measured by at least a 7-point decrease in Lee Symptom Scale score. Additionally, a reduction in steroid dose <0.15 mg/kg/day was reached in 62% of patients with a complete or partial response. Twelve patients (29%) remained on treatment at the time of this analysis.

Patients can develop GVHD, a serious and debilitating condition in which their body is attacked by donor immune cells, after undergoing an allogeneic stem cell or bone marrow transplant. The condition can be acute or chronic; cGVHD usually starts more … Continue reading CCL Dec 2016 – Imbruvica Shows Response in 2/3 of Steroid Dependent, Refractory cGVHD Patients in Phase II Study

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