AMSTERDAM, June 16, 2012 /PRNewswire/ -- Pharmacyclics, Inc (Nasdaq: PCYC) announced today at the 17th Congress of European Hematology Association updated results from two clinical trials of Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib (PCI-32765), for the treatment of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
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). The trial results of PCYC-1102 were updated at EHA with progression-free survival (PFS) data from the relapsed/refractory CLL/SLL patients, including PFS data for high-risk 17p deletion CLL patients, and newly presented immunoglobulin data in the treatment naive patients with a median follow up of 14.4 months. The trial results of PCYC-1108 were updated at EHA with three patients that received an ibrutinib combination with fludarabine/cyclophosphamide/rituximab (FCR).
Abstract # 1970: The Bruton's Tyrosine Kinase Inhibitor Ibrutinib (PCI-32765) is Highly Active and Tolerable in Relapsed or Refractory and Treatment Naive Chronic Lymphocytic Leukemia Patients, Updated Results of a Phase Ib/II Study.
Dr. Susan M. O'Brien et al. MD Anderson Cancer Center, Houston, Texas.
- 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 (N = 27).
- High risk relapsed/refractory patients with 17p deletion (N=20) and IgVH unmutated status (N=42), have an estimated 18-month PFS of >70% and >80%, respectively.
- As previously presented at the American Society of Clinical Oncology Annual Meeting (ASCO), in the treatment naive patients, overall response rate in the 420 mg cohort (N=26) 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.
- 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 (MRD-Negative) complete responses.