Incyte Corporation (INCY) 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 (TATD). 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.V). 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 Novartis (NVS) 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 thrombocythemia MF.
Incyte, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the sector include Gilead Sciences Inc. (GILD) and Alexion Pharmaceuticals, Inc. (ALXN). While Gilead sports a Zacks Rank #1 (Strong Buy), Alexion holds a Zacks Rank #2 (Buy).
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