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news.US-based biopharmaceutical firm Pharmacyclics has reported positive results from its Phase II investigator-initiated trial of Imbruvica (ibrutinib) in patients with Waldenstrom's macroglobulinemia (WM).
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The trial showed that WM patients treated with Imbruvica experienced sustained disease control with an overall response rate (ORR) of 91% after a median of 19.1 months of treatment and a two-year overall survival (OS) rate of 95%.
An earlier analysis of the data served as the basis for the January 2015 US Food and Drug Administration (FDA) approval of Imbruvica to treat all patients with WM.
Pharmacyclics and Janssen Biotech are jointly developing and commercializing Imbruvica.
Dana-Farber Cancer Institute director of the Bing Center for Waldenstrom Macroglobulinemia and Harvard Medical School associate professor Steven Treon said: "The results are remarkable when you consider that patients had received an average of two prior therapies, and 40% showed no response to the previous treatments.
"The findings herald a new era for the treatment of Waldenstrom’s macroglobulinemia."
A total of 63 previously treated patients who had received a median of two prior therapies were included in the prospective, open-label, multi-center Phase II trial, which evaluated the safety and tolerability of Imbruvica 420mg orally, once daily until disease progression or unacceptable toxicity.
Pharmacyclics head of Hematology and Global Medical Safety Thorsten Graef said: "The strength of these results are compelling, as they reinforce earlier data on which Imbruvica was approved for Waldenstrom’s macroglobulinemia and show even greater efficacy in difficult-to-treat patients."