ASH Annual Meeting Oral Presentation The Bruton's Tyrosine Inhibitor Ibrutinib (PCI-32765) is Active and Tolerated in Relapsed Follicular Lymphoma Nathan Fowler, M.D. Dept of Lymphoma, UT MD Anderson Cancer Center, Houston, TX Long term results on 16 relapsed / refractory evaluable follicular patients dosed with ibrutinib as monotherapy from the Phase I dose escalation study (PCYC-04573) were presented. Patients were heavily pretreated with a median of 3 prior therapies, and 44% had high risk Follicular Lymphoma International Prognostic Index scores. The ORR in 16 subjects was 44% with 3 CRs and 4 PRs. For those patients with at least 1 tumor response assessment, the media PFS in dose cohorts greater or equal 2.5 mg/kg (n=11) was reported at 13.4 months with an ORR=55%. With patients treated at greater or equal 5 mg/kg (n=9) the median PFS was reported as 19.6 months with an ORR=56%. The drug was well tolerated with no apparent cumulative toxicity upon extended dosing in this study.ASH Annual Meeting Poster Presentation Multiple Myeloma (MM) Early Changes in Cytokines, Chemokines and Indices of Bone Metabolism in a Phase 2 Study of the Bruton Tyrosine Kinase (Btk) Inhibitor, Ibrutinib (PCI-32765) in Patients with Relapsed or Relapsed/Refractory MM Ravi Vij, M.D., Washington University, School of Medicine, Saint Louis, MO This poster presented clinical results and biomarker studies on 13 MM patients accrued in the first cohort where ibrutinib monotherapy was dosed at 420mg. Patients were heavily pretreated, with a median of 4 prior therapies (range 2 to 10). All patients previously had prior exposure to bortezomib, lenalidomide, and dexamethasone or prednisone and 92% had progressed following stem cell transplant. A total of 39% of the patients had del17p. Signals of biologic and clinical activity were observed. Reductions in paraprotein of at least 50% were observed in 3 patients on ibrutinib monotherapy, and one patient went on to have a confirmed PR following addition of dexamethasone. As anticipated from pre-clinical studies, decreases of several biomarkers of bone metabolism, angiogenesis and chemotaxis were observed following the start of treatment. The most common treatment related adverse events were Grade 1/2 nausea and diarrhea. We have expanded the study to explore ibrutinib administration at 840 mg and a 560 mg dose in combination with dexamethasone. As we obtain further data from these cohorts over the next 12 months, we will assess the clinical outcome of ibrutinib in this patient population.
Pharmacyclics® Announces Updated Results For BTK Inhibitor Ibrutinib (PCI-32765) At American Society Of Hematology (ASH) Annual Meeting
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