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Pooled Overall Survival Analysis of 5-Year Data from COMFORT-I and COMFORT-II
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The Janus kinase (JAK) 1/JAK2 inhibitor ruxolitinib has been evaluated for patients with MF in the phase 3 COMFORT studies. In both trials, ruxolitinib prolonged OS, reduced splenomegaly, and improved MF-related symptoms and quality of life compared with controls. Here, we report the results of an exploratory pooled analysis of OS in the COMFORT studies at 5 years of follow-up.

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Hello, I am Srdan Verstovsek, Professor of Medicine in the Leukemia Department at MD Anderson Cancer Center in Houston. I'm here at the Annual American Society of Hematology Meeting where I am presenting a summary, a long term follow up of two studies called COMFORT-I and COMFORT-II studies where ruxolitinib, a new therapy for myelofibrosis, was compared to standard of care or placebo which led to approval of this drug several years ago, is now standard of care therapy for patients with advanced myelofibrosis.

What I'm presenting here at the AASH is the survival benefit that is now becoming more obvious over time as we treat patients with ruxolitinib. In these two studies, COMFORT-I and COMFORT-II studies, comparison was made to best available therapy or placebo with a caveat that patients were actually allowed to cross over to ruxolitinib if they were not doing well on those comparison arms. So, great majority of the patients actually did cross over to ruxolitinib after few months of a therapy on comparison arm. Now, despite that crossover design now, it's obvious more than before that there is a survival advantage to ruxolitinib versus those comparison arms. We see an average prolongation of alive of about 30%, which comes down to about a year and a half longer life for patients with advanced myelofibrosis. Remember, participants in this study were intermediate-2 or high-risk patients with myelofibrosis so advanced features with a short life expectancy.

Further analysis proved that in patients that did not cross over to ruxolitinib, they were maintained on the comparison arms and never exposed to ruxolitinib, the survival advantage is even more obvious. It doubles to about three years on average. So, that makes a good case to introduce ruxolitinib earlier on in the development of the disease and not to wait for patients to have a very advanced features and very short life expectancy. This is supported even more by sub-analysis of patients that actually at the ends of the studies had intermediate-2 or the high-risk features. The survival benefit is much more obvious in patients with intermediate-2 than high-risk features. So, again, the message here is that we do prolong life over the patients with the ruxolitinib patients with myelofibrosis, and that earlier intervention appears to bring the benefit of alive extension much more if you introduce the drug earlier.

I should also add from other analysis not currently presented here, that it's quite obvious that the degree of a spleen reduction in COMFORT-I and COMFORT-II and prior Phase 1 and 2 studies is the main factor that would tell us how long the patient is going to stay on the study and how long the patient is going to live while treated with ruxolitinib. The better the spleen response, the longer survival of the patients. I thank you very much, this was a short summary from this Annual American Society of Hematology Meeting here in San Diego. Thank you.