) announced encouraging results from its phase III RESPONSE trial
on its sole marketed product, Jakafi. Results were presented at the
annual meeting of the American Society of Clinical Oncology (ASCO).
Incyte's shares gained around 4.3% following the news.
The RESPONSE trial evaluated Jakafi in comparison to best available
therapy in the treatment of polycythemia vera (PV). Results
revealed that 77% of patients under the Jakafi arm at week 8
achieved the primary endpoint of hematocrit control and/or a
minimum of 35% reduction in spleen volume, compared to 20% of
patients under best available therapy. Moreover, 91% of the
patients who attained the primary endpoint in the Jakafi arm
maintained the response at week 48.
Results further revealed that 24% patients under Jakafi treatment
had complete hematologic remission compared to a mere 9% on best
available therapy. Moreover, results illustrate that a greater
proportion of patients under Jakafi treatment showed meaningful
improvement in other PV-related symptoms compared to patients under
best available therapy.
Results from the RESPONSE trial will support Incyte's regulatory
filing (for the PV indication of Jakafi) in the U.S., which is
scheduled later in this month. The company further stated that if
approved, Jakafi will be the first JAK1/JAK2 inhibitor, to be
available for patients suffering from PV.
Jakafi was launched in the U.S. in Nov 2011, for treating patients
suffering from intermediate or high-risk MF. Jakafi contributed
around $69.7 million to Incyte's top line in the first quarter
2014, representing an increase of 44% from the year-ago quarter. We
are encouraged by Incyte's progress with Jakafi. Successful label
expansion of the drug will drive sales further.
Incyte has a collaborative agreement with
) to market Jakafi outside the U.S. The drug has also been approved
by the European Commission to treat adults suffering from primary
myelofibrosis (MF), post-polycythemia vera MF or post-essential
Incyte, a biopharmaceutical company, currently carries a Zacks Rank
#3 (Hold). Some better-ranked stocks in the sector include
Gilead Sciences Inc.
Alexion Pharmaceuticals, Inc.
). While Gilead sports a Zacks Rank #1 (Strong Buy), Alexion holds
a Zacks Rank #2 (Buy).
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