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Incyte Reports Five-Year Data from Phase III Study on Jakafi
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Incyte Corporation (INCY - Free Report) announced five-year data from a phase III study (COMFORT-I) on Jakafi for the treatment of patients with intermediate-2 or high-risk myelofibrosis (MF).
The randomized, double-blind, placebo-controlled study evaluated the long-term safety and efficacy of Jakafi, compared to placebo, in patients (n=309) with intermediate-2 or high-risk primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF.
Data from the study demonstrated a 31% reduction in the risk of death in patients treated with Jakafi compared to the placebo arm. Results also revealed that 59% of the patients who continued on treatment with Jakafi achieved at least a 35% reduction in spleen volume at any given time.
We note that Jakafi is currently approved in the U.S. for the treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also approved for the treatment of patients with intermediate or high-risk MF, including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF. The company has a collaboration agreement with Novartis AG (NVS - Free Report) for the commercialization of Jakavi in ex-U.S. markets.
In the first quarter of 2016, Jakafi recorded sales of $183.3 million, up 58.9% year over year. The company has raised its guidance for net product sales from Jakafi in 2016 to the range of $815 million to $830 million (old guidance: $800–$815 million).
Meanwhile, Incyte is working on expanding Jakafi’s label. In Apr 2016, the company acquired the rights to develop and commercialize Jakafi from Eli Lilly and Company (LLY - Free Report) for the treatment of graft-versus-host disease (GVHD). A phase III study on Jakafi for GVHD is expected to begin in the second half of the year.
However, the company discontinued the evaluation of Jakafi in two phase III studies – JANUS 1 for the second-line treatment of advanced or metastatic pancreatic cancer and JANUS 2 study for the treatment of pancreatic cancer. The decision was made after a planned interim analysis of the JANUS 1 study demonstrated that Jakafi, in combination with Xeloda (capecitabine), failed to show a sufficient level of efficacy to warrant continuation.
Currently, Incyte carries a Zacks Rank #3 (Hold). Bristol-Myers Squibb Company (BMY - Free Report) is a better-ranked stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy).
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Incyte Reports Five-Year Data from Phase III Study on Jakafi
Incyte Corporation (INCY - Free Report) announced five-year data from a phase III study (COMFORT-I) on Jakafi for the treatment of patients with intermediate-2 or high-risk myelofibrosis (MF).
The randomized, double-blind, placebo-controlled study evaluated the long-term safety and efficacy of Jakafi, compared to placebo, in patients (n=309) with intermediate-2 or high-risk primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF.
Data from the study demonstrated a 31% reduction in the risk of death in patients treated with Jakafi compared to the placebo arm. Results also revealed that 59% of the patients who continued on treatment with Jakafi achieved at least a 35% reduction in spleen volume at any given time.
We note that Jakafi is currently approved in the U.S. for the treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also approved for the treatment of patients with intermediate or high-risk MF, including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF. The company has a collaboration agreement with Novartis AG (NVS - Free Report) for the commercialization of Jakavi in ex-U.S. markets.
In the first quarter of 2016, Jakafi recorded sales of $183.3 million, up 58.9% year over year. The company has raised its guidance for net product sales from Jakafi in 2016 to the range of $815 million to $830 million (old guidance: $800–$815 million).
Meanwhile, Incyte is working on expanding Jakafi’s label. In Apr 2016, the company acquired the rights to develop and commercialize Jakafi from Eli Lilly and Company (LLY - Free Report) for the treatment of graft-versus-host disease (GVHD). A phase III study on Jakafi for GVHD is expected to begin in the second half of the year.
However, the company discontinued the evaluation of Jakafi in two phase III studies – JANUS 1 for the second-line treatment of advanced or metastatic pancreatic cancer and JANUS 2 study for the treatment of pancreatic cancer. The decision was made after a planned interim analysis of the JANUS 1 study demonstrated that Jakafi, in combination with Xeloda (capecitabine), failed to show a sufficient level of efficacy to warrant continuation.
Currently, Incyte carries a Zacks Rank #3 (Hold). Bristol-Myers Squibb Company (BMY - Free Report) is a better-ranked stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.Click to get this free report >>