Phase II study of PCI 32765 (Pharmacyclics Inc) shows some benefits in patients with Mantle Cell Lymphoma

Findings from an ongoing, open-label, Phase II, single-agent study shows that in patients with relapsed or refractory Mantle Cell Lymphoma (MCL), PCI 32765 (ibrutinib), from Pharmacyclics Inc., resulted in an overall response rate of 68 percent, including a complete response of 22 percent and a partial response of 46 percent. The study included both bortezomib-naive and bortezomib-exposed patients; 111 received ibrutinib and 110 were evaluable for efficacy. Median follow-up time was 9.2 months, with a range of time to response to treatment of 1.4 to 16.4 months.

Among the study's secondary endpoints, the median progression-free survival (PFS) with ibrutinib was 13.9 months. Additionally, the median time to response to treatment with ibrutinib was 1.9 months for first PR (range of 1.4 to 9.1 months) and 5.5 months for first CR (range of 1.7 to 16.4 months). results were presented by lead investigator Michael L. Wang, associate professor in the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center, at the 54th Annual Meeting of the American Society of Hematology.