Incyte Corporation (INCY) announced the publication of data from a pivotal phase III study (RESPONSE) on Jakafi in the New England Journal of Medicine. The study compared Jakafi to standard therapy in patients with polycythemia vera (PV) who have had an inadequate response or are intolerant to hydroxyurea.
We remind investors that last month, Jakafi was approved by the FDA for the treatment of patients with uncontrolled PV, making it the first and only FDA approved treatment for this indication.
Results from the global, randomized, open-label phase III study (n=222) revealed that 77% of patients when treated with Jakafi achieved one or both components of the primary endpoint compared to 20% of patients under standard therapy.
Moreover, 91% of patients who attained the primary endpoint in the Jakafi arm maintained the response at week 48. Results further revealed that 24% of patients under Jakafi treatment achieved complete hematologic remission compared to 9% of patients on standard therapy.
According to the press release issued by Incyte, PV affects nearly 100,000 patients in the U.S. alone, out of which roughly 25,000 patients are resistant or intolerant to hydroxyurea.
We note that Jakafi is also approved in the U.S. for the treatment of patients suffering from intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF.
We remind investors that Incyte has an agreement with Novartis (NVS) for the development and commercialization of Jakavi in ex-U.S. markets.
Late last week, Incyte earned a milestone payment of $25 million from Novartis following a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use favoring the approval of Jakavi for the PV indication.
Meanwhile, Incyte is working on expanding Jakafi’s label further and is evaluating the drug for indications like advanced or metastatic pancreatic cancer and non-small cell lung cancer among others.
Incyte currently carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the health care sector include Alexion Pharmaceuticals, Inc. (ALXN) and Celgene Corp. (CELG). Both carry a Zacks Rank #1 (Strong Buy).
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