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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.

Dr. Jennifer Brown et al. Dana-Farber Cancer Institute, Boston, Massachusetts.

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.
continued- PCYC
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.