Conference Correspondent

ASH 2016 - Chronic Lymphocytic Leukemia

Treatment with ibrutinib in patients with chronic lymphocytic leukemia (CLL) or mantle-cell lymphoma who had disease progression following allogeneic stem-cell transplantation resulted in a 77% overall response rate with a predicted 1-year overall survival of 92%.
In the prospective, open-label, multicenter, phase 2 CLL2-BIG trial, induction treatment with obinutuzumab and ibrutinib followed by maintenance therapy with continuous ibrutinib and obinutuzumab in a heterogeneous CLL population resulted in an overall response rate of 100% and an minimal residual disease–negativity rate of 47% in the peripheral blood, with no major toxicity.
In a multicenter, retrospective analysis of 683 patients with chronic lymphocytic leukemia (CLL), relative efficacy and optimal sequencing of ibrutinib (Ibr), idelalisib (Ide), and venetoclax (Ven) were evaluated. Using overall response rate and progression-free survival as clinical end points, Ibr appears superior to Ide in all settings as first choice kinase inhibitor (KI). In the setting of KI failure, an alternate KI or Ven therapy appears superior to chemoimmunotherapy, whereas an alternate KI appears particularly effective in the setting of intolerance to a prior KI. The use of Ven upon Ibr failure may be superior to the use of Ide. These data provide guidance for sequencing of novel agents.
Healthcare utilization of chronic lymphocytic leukemia (CLL) patients who remain on bendamustine-rituximab (BR) is significantly lower than patients who remain on fludarabine, cyclophosphamide, and rituximab (FCR). Patients aged ≥70 years receiving FCR experienced significantly more days of hospitalization, outpatient visits, and emergency department visits than patients of the same age treated with BR, suggesting BR as an effective, safe, and value-based treatment option for elderly CLL patients.
In chronic lymphocytic leukemia patients with chronic graft-versus-host disease (cGVHD) following allogeneic stem-cell transplantation, treatment with ibrutinib resulted in clinically meaningful and durable responses in patients who had failed at least 1 prior treatment for cGVHD, with a sustained overall response rate of 71% for ≥20 weeks.
Using a novel electronic health record database that included nearly 800 chronic lymphocytic leukemia (CLL) patients, recent (2015-2016) treatment patterns in the United States showed a decline in the use of fludarabine-, bendamustine-, and rituximab-containing regimens and a significant increase in the use of obinutuzumab and ibrutinib, either as monotherapy or in combination regimens. The uptick in use of ibrutinib was especially noted in CLL patients with del17p. The increased utilization of newer agents requires further follow-up and analysis to contrast treatment patterns beyond clinical trial data in a real-world setting and a cost-effectiveness analysis. 
Obinutuzumab, ibrutinib, and venetoclax can be safely administered in combination at doses standard for the treatment of patients with CLL, with manageable adverse events that were largely consistent with those reported in single-agent studies. Objective responses, including minimal residual disease–negative responses, were observed among all patients with relapsed/refractory CLL.
Using an ad hoc analysis of data from the RESONATE study, changes in clinical staging (by Binet or Rai) can identify different response categories among patients evaluated by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria, and may be a useful and cost-effective method to evaluate treatment response at different time points over the course of the disease. Using this approach, the superiority of ibrutinib over ofatumumab in heavily pretreated CLL patients was confirmed and further elucidated.
Pembrolizumab has an acceptable safety profile in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) and Richter’s syndrome (RS) patients and substantial therapeutic activity in RS. However, single-agent pembrolizumab does not appear to have significant therapeutic activity in R/R CLL.
An integrated safety analysis of treatment with single-agent ibrutinib for up to 5 years for patients with treatment-naïve or relapsed/refractory CLL/SLL revealed adverse events that were primarily grade 1/2 and were manageable with prolonged treatment.
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