Pharmacyclics Announces Ibrutinib Frontline Chronic Lymphocytic Leukemia Study Results Published in The Lancet Oncology
Pharmacyclics (NASDAQ: PCYC) today announced that The Lancet Oncology published results of a study evaluating ibrutinib in previously untreated elderly patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The Phase 1b/2 open-label, multicenter study evaluated 31 patients, 65 years of age and older with CLL or SLL. The primary endpoint of the study was safety, as assessed by the frequency and severity of adverse events (AEs), while the secondary objectives assessed the clinical activity of single agent ibrutinib. Only one patient out of the 31 enrolled in this cohort has had progression of disease.
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.