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|New Data for Jakafi® (ruxolitinib) Presented at the 2012 American Society of Hematology Annual Meeting|
Of 24 Jakafi-related abstracts accepted for presentation at ASH, six are oral presentations. Two of the oral presentations highlight long-term results from both COMFORT-I and COMFORT-II in which patients with MF treated with Jakafi had improved survival over placebo and best available therapy, suggesting an overall survival benefit in patients with intermediate or high-risk MF. Additionally, data from this longer-term two-year follow-up show that improvements in quality of life measures and reductions in spleen volume were maintained with continued treatment.
Other data presented at ASH include results from a three-year follow-up of patients with polycythemia vera (PV) in a Phase II study, showing that ruxolitinib treatment resulted in durable response rates by modified European Leukemia Net criteria and improvements in PV-related symptoms.
“The long-term data for Jakafi continue to demonstrate tangible benefits
for patients with myelofibrosis, including better management of this
progressive and debilitating disease and an apparent improvement in
overall survival,” stated Srdan Verstovsek, M.D., Ph.D., Professor,
“In addition to the promising overall survival data from the two COMFORT
trials, exploratory analyses of the COMFORT-I trial provided additional
guidance on dose titration. We’re confident this information will help
physicians find the optimal dose for each patient and maintain long-term
treatment with Jakafi, providing the potential for longer survival,”
Highlights of Key Data Presented
In two Phase III randomized clinical studies, COMFORT-I and COMFORT-II, Jakafi was associated with a survival advantage over placebo and best available therapy, respectively. In COMFORT-I, reductions in spleen volume continued to be observed over two years of treatment. Spleen volume was reduced by 32 percent at week 24 with Jakafi treatment, and this reduction was sustained through week 96. Improvements in quality of life measures also continued to be observed over two years of treatment. Additionally, rates of grade 3 or 4 anemia and thrombocytopenia decreased with long-term therapy, and there was no apparent change in the frequency or severity of non-hematologic adverse events.
Survival analyses were conducted at a two-year follow-up in COMFORT-I and COMFORT-II, comparing patients randomized to Jakafi with those randomized to placebo and best available therapy, respectively. In COMFORT-I, Jakafi continued to be associated with a survival advantage over placebo. There were 27 deaths in the group treated with Jakafi, and 41 in the placebo group, representing a HR=0.58 (95% CI, 0.36-0.95; P = 0.028). Overall survival favored treatment with Jakafi regardless of JAK2V617F mutation status. Similarly, an updated analysis of COMFORT-II suggested longer survival for patients randomized to Jakafi when compared to those randomized to best available therapy. In this study, where twice as many patients were randomized to Jakafi (146) as to placebo (73), there were 14 percent (n=20) deaths in the group treated with Jakafi and 22 percent (n=16) in the best available therapy group, representing a HR=0.51 (95% CI, 0.26-0.99; P = 0.041). These survival benefits were observed even though all patients in the placebo and best available therapy groups continuing in the COMFORT studies were switched to Jakafi treatment soon after the primary analyses, suggesting that earlier initiation of treatment with Jakafi may have contributed to longer survival.
In a Phase II clinical trial of patients (n=34) with polycythemia vera (PV) who are resistant or intolerant to hydroxyurea, ruxolitinib treatment resulted in clinical benefit by providing durable overall response rates by modified European Leukemia Net criteria as well as ameliorating symptoms commonly associated with PV, such as itching, night sweats and bone pain. Overall response was achieved in 97 percent of patients at week 24. Of these responders, 74 percent maintained overall response at week 144. Anemia and thrombocytopenia (primarily grade 1) were the most common adverse events.
The slides used during the presentation can be accessed at: 2012 ASH Oral_Verstovsek_PV.
Other data related to Jakafi presented orally at ASH include:
The following presentations related to Jakafi were exhibited during poster sessions at ASH:
About the Webcast
Jakafi is a prescription medicine used to treat people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF.
Important Safety Information
For Full Prescribing Information for Jakafi, visit www.Jakafi.com.
About the Incyte-Novartis Worldwide Collaboration and License Agreement
COMFORT-I was conducted by
Except for the historical information contained herein, the matters set forth in this press release, including statements with respect to the potential efficacy, safety and therapeutic value of Jakafi® (ruxolitinib), including statements that there may be an overall survival benefit, or advantage or improvement with treatment with Jakafi, that earlier initiation of treatment with Jakafi may contribute to longer survival, that additional guidance on dose titration may provide information to help physicians find the optimal dose for each patient and maintain long-term treatment with Jakafi, providing the potential for longer survival, and the potential use of ruxolitinib to treat patients with polycythemia vera, contain predictions and estimates and are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially, including
unanticipated developments in and risks related to the efficacy or
safety of Jakafi, the results of further research and development, the
high degree of risk and uncertainty associated with drug development and
clinical trials, and other risks detailed from time to time in
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The information in the press releases should be considered accurate only as of the date of the document or presentation. We disclaim any obligation to supplement or update the information in these documents or presentations.
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