Biotech Values

[mcbio]

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.

Note too that also presented at ASCO was a Phase 1b/2 study of ibrutinib in combo with ofatumumab. There was a 100% response rate in this study in relapsed/refractory CLL/SLL/PLL patients.

http://ir.pharmacyclics.com/releasedetail.cfm?ReleaseID=679669

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%.


The combination trial (PCYC-1109) included a total of 27 patients with CLL/SLL/PLL (n=24) and Richter's transformation (n=3) that were treated in cohort one, in which ibrutinib (420 mg) was followed by concomitant ofatumumab with continued ibrutinib until progression. The combination was well tolerated with the majority of adverse events Grades 1/2. No new safety signals were identified. For the CLL/SLL/PLL patients the overall response rate, as measured by IWCLL criteria, and progression free survival is 100% with a median follow-up of 9.8 months. 89% of CLL/SLL/PLL patients remain on study and only 1 patient has discontinued treatment by proceeding to stem cell transplant. Achievement of 100% tumor response, rapid onset of response, low relapse rate with durable responses, and a favorable safety profile make this combination worthy of further study. Cohorts evaluating other therapeutic sequences are currently underway.