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To: The Ox who wrote (1978)6/20/2013 9:19:11 AM
From: The Ox  Read Replies (2) | Respond to of 8239
 
2:43AM Pharmacyclics: Ibrutinib Phase 2 study results in patients with mantle cell lymphoma published in The New England Journal of Medicine ( PCYC) 84.70 : Co announces that The New England Journal of Medicine published results of a Phase 2 study evaluating the investigational oral Bruton's tyrosine kinase inhibitor ibrutinib in patients with relapsed/refractory mantle cell lymphoma online. These data suggested ibrutinib may be effective and generally well-tolerated in patients with relapsed/refractory MCL.

The study evaluated 111 patients with relapsed/refractory MCL treated with ibrutinib. The majority of patients (86%) had intermediate or high-risk MCL and had previously undergone treatment with a median of three prior therapies before enrollment in the study. Patients were enrolled in two cohorts based on whether they had prior exposure to bortezomib. Overall response rate across both cohorts was 68% with 47% of patients achieving a partial response and 21% achieving a complete response where all signs of cancer are gone. The estimated median response duration was 17.5 months. The median progression free survival was 13.9 months and while the median overall survival for this study has not yet been reached it is estimated to be 58% at 18 months. The overall response to ibrutinib was independent of prior treatment including bortezomib and lenalidomide or underlying risk/prognosis, bulky disease, gender or age. In an initial subset of patients enrolled in the study who have the longest follow up, the response to ibrutinib increased with longer duration of treatment, with the complete response rate increasing from 16% at a median follow-up of 3.7 months to 37% at a median follow-up of 18.2 months