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.
This trial (PCYC-1102) included a total of 92 patients with CLL/SLL (61 relapsed/refractory patients and 31 treatment-naive patients) enrolled at two fixed continuous dose levels of ibrutinib single agent (420 mg and 840 mg). In addition to the data reported
Abstract # 1590: Combination of the Bruton's tyrosine kinase inhibitor PCI-32765 with bendamustine/rituximab (BR) in patients with relapsed/refractory chronic lymphocytic leukemia: Interim results of a phase Ib/II study.
This combination trial (PCYC-1108) enrolled a total of 30 patients in the BR cohort; 37% were considered refractory (treatment free interval < 12 mo) to a purine analog containing regimen and 13% refractory to bendamustine. As previously reported at ASCO, there have been no discontinuations due to adverse events. With a median follow up of 8.1 months only 2 patients have reported progressive disease and an additional 5 patients have proceeded to stem cell transplant, 23 (77%) of patients remain on study. In addition to the ibrutinib plus BR data recently reported at ASCO the FCR combination study cohort (N=3) was presented at EHA. It required patients to be fludarabine naive and due to poor enrollment the cohort was suspended. With a median follow-up of 8.5 months all three patients have achieved an objective response, with two patients achieving minimal residual disease negative (MRD-Negative) complete responses and all patients remain progression free. The high overall response rate, rapid onset of response, low rate of progressive disease and good tolerability compares favorably with historical controls, warranting a randomized Phase 3 study of ibrutinib in combination with bendamustine/rituximab.
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