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Two Novartis Phase III Studies Show Twice as Many Ph+ CML Patients Achieve Deeper Levels of Response With Tasigna® Compared to Gleevec®
Date:12/12/2011

e amount of 0.0032% or less of Bcr-Abl compared to Gleevec (32% taking Tasigna 300 mg twice daily and 15% taking Gleevec 400 mg once daily). The ENESTnd study also continued to show that first-line treatment with Tasigna resulted in significantly fewer patients progressing to advanced phase and blast crisis (AP/BC) stages of disease compared to Gleevec, leading to a significantly lower number of CML-related deaths in patients taking Tasigna versus Gleevec (p=0.0356)(2).

"Data from both ENESTnd and ENESTcmr reinforce that patients taking Tasigna have a greater chance of achieving CMR, the deepest level of response measurable today, compared to those taking Gleevec," said Timothy P. Hughes, MD, ENEST study investigator and Clinical Professor at the University of Adelaide, Australia. "We are encouraged by what we saw in ENESTcmr and further follow-up on both trials should help to determine if more patients can reach undetectable levels of CML over time, which could have important implications for determining criteria for future studies on discontinuation of therapy."

CML is a disease in which the body produces cancerous white blood cells. Almost all patients with CML have an abnormality known as the Philadelphia chromosome, which is comprised of a protein called Bcr-Abl that causes malignant white blood cells to proliferate(3). The success of treatment for CML can be measured by a test called real-time quantitative polymerase chain reaction (RQ-PCR). A molecular response means RQ-PCR shows a reduction in Bcr-Abl in the blood; a CMR means no Bcr-Abl is detected(4,5).

"Data from the ENESTnd 36-month update and the ENESTcmr trial at ASH continue to reinforce the benefits of Tasigna over Gleevec, and support the use of Tasigna for adult patients with chronic-phase Ph+ CML," said Herve Hoppenot, President, Novartis Oncology. "We look forward to even more progress in the future as we observe the impact of achieving deep and sustained molecula
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