Ibrutinib's 100% only with ofatumumab:
1: Abstract # 6508: A phase Ib/II study evaluating activity and tolerability of BTK inhibitor PCI-32765 and ofatumumab in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and related diseases.
Dr. Samantha Mary Jaglowski et al. The Ohio State University, Columbus, Ohio.
Most adverse events were Grade 1 and 2, and commonly reported Grade 3 infectious events were as expected in this patient population
Overall response rate is 100% in CLL/SLL/PLL patients. Progression free survival with a median follow-up of 9.8 months is 100%.
single-agent:
2: Abstract # 6507: The Bruton's tyrosine kinase inhibitor PCI-32765 in treatment-naïve chronic lymphocytic leukemia patients: Interim results of a phase Ib/II study.
Dr. John C. Byrd et al., The Ohio State University, Columbus, Ohio.
Non-hematologic toxicities of ibrutinib single agent remain manageable and tolerable with no new signals; hematologic toxicities were uncommon.
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.
final results: ORR 71%
Ibrutinib Frontline Chronic Lymphocytic Leukemia Study Results Published in The Lancet Oncology
After a median follow-up of 22.1 months (range, 18.4-23.2), the overall response rate (ORR) for patients was 71 percent (95% CI, 52-86), which included 55 percent partial response, 3 percent nodular partial response and 13 percent complete response. An additional 13 percent of patients achived a partial response with lymphocytosis. The median time to initial response was 1.9 months (range, 1.5-7.4); the median time to best response and complete response were 5.9 months (range, 1.8-22.1) and 12.0 months (range, 7.1-15.6), respectively.
3: Ibrutinib Study Results in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia Published in The New England Journal of Medicine
study participants were enrolled selected to receive either ibrutinib 420 mg (n=51) or 840 mg (n=34) as a once-daily, oral monotherapy. Both doses were associated with overall response rates of 71 percent.
