THERE IS AN AMAZING DISCONNECT BETWEEN THE VALUE OF PCYC AND THE MARKET’S PERCEIVED VALUE OF PCYC.
PLEASE READ. REMARKABLE.
Pharmacyclics: IMBRUVICA data demonstrates efficacy in previously untreated and relapsed/refractory high-risk chronic lymphocytic leukemia patients Font size: A | A | A
9:04 AM ET 1/5/15 | Briefing.com
Co announces that treatment with single-agent IMBRUVICA in treatment-naive and previously treated patients with chronic lymphocytic leukemia resulted in a significant response rate, with 92% of high-risk CLL patients with deletion 17p or tumor protein 53 achieving an objective response. These high-risk patients typically do not respond well to standard therapies.
The Phase II, open-label, single-center study enrolled 51 CLL patients at the National Institutes of Health Clinical Center. Thirty-five patients had previously untreated disease and 16 patients had relapsed or refractory CLL. The primary endpoint of the study was overall response rate after 24 weeks, and secondary endpoints included safety, overall survival, progression-free survival, best response and nodal response. Forty-seven of the 51 patients (92%) enrolled in this study had del 17p CLL and four patients carried the TP53 aberration but did not have the del 17p mutation.
At the time of analysis, the median follow-up for all patients was 24 months (15 months for the previously untreated cohort). At 24 weeks, 48 patients were evaluable for response, assessed according to the modified International Workshop on Chronic Lymphocytic Leukemia 2008 criteria. Ninety-two percent of patients achieved an objective response, 50% achieved a partial response and 42% achieved a PR with lymphocytosis. The ORR rate and depth of responses increased over time.
The estimated PFS at 24 months for all patients on an intention-to-treat basis was 82%. Forty-two of the 51 patients enrolled in the study continued on IMBRUVICA treatment without disease progression. After eight weeks on therapy, IMBRUVICA was associated with a > 50% mean reduction in tumor burden in the bone marrow (44%), lymph nodes (70%) and spleen (79%) in patients. After 24 weeks of therapy, the rates of tumor burden reduction (> 50%) increased to 83%, 93% and 95%, respectively.