12:38AM Pharmacyclics provides updated results for BTK inhibitor Ibrutinib (PCYC) 41.23 : Co provides results from two clinical trials of Bruton's tyrosine kinase inhibitor, ibrutinib, for the treatment of patients with chronic lymphocytic leukemia/small lymphocytic lymphoma. The ibrutinib clinical updates at EHA released in two oral presentations include: 1) updated safety and efficacy data from the Phase Ib/II CLL/SLL single agent trial (PCYC-1102); and 2) updated safety and efficacy data from the Phase Ib/II CLL/SLL combination trial with bendamustine and rituximab in relapsed or refractory patients (PCYC-1108). Highlights of study 1 include: (-) Non-hematologic toxicities of ibrutinib single agent remain manageable and tolerable with no new signals; hematologic toxicities were uncommon. (-) PFS with a median follow-up of 17.5 months is 87.7% in the relapsed/refractory 420 mg cohort. (-) High risk relapsed/refractory patients with 17p deletion and IgVH unmutated status, have an estimated 18-month PFS of >70% and >80%, respectively. (-) As previously presented, in the treatment naive patients, overall response rate in the 420 mg cohort is 81% using ibrutinib as a single agent. 12% of patients achieved a complete response with no morphologic evidence of CLL. Progression free survival with a median follow-up of 14.4 months is 96% in the 420 mg cohort. The Second study highlights include: (-) Adverse events are consistent with previous reports of the BR and FCR combination. No new safety signals with the combination of ibrutinib and BR were identified. (-) As previously presented at ASCO, overall response rate with BR is 93%, with 13% of patients achieving a complete response with no morphologic evidence of CLL. (-) At 8.5 months of median follow-up all three patients that received ibrutinib in combination with FCR remain progression free with two achieving minimal residual disease negative complete responses.
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