Incyte's Jakafi Positive in Phase III for Polycythemia Study

Incyte Corporation INCY announced new 28-week data from a phase III study (RESPONSE-2) on Jakafi for the treatment polycythemia vera (PV).

The multi-center, open-label, randomized study evaluated the safety and efficacy of Jakafi, in comparison to the best available therapy, in patients with PV who are resistant to or intolerant of hydroxyurea, dependent on phlebotomy for hematocrit control and do not have an enlarged spleen.

Data from the study demonstrated that 62% of patients treated with Jakafi achieved hematocrit control without phlebotomy, compared to the 18% of patients treated with the best available therapy. Results were presented at the Congress of the European Hematology Association.

Jakafi was generally well tolerated. Results from the RESPONSE-2 study were consistent with data from the RESPONSE study, which evaluated patients suffering from inadequately controlled PV with an enlarged spleen.

We note that Jakafi is currently approved in the U.S. for the treatment of patients with PV 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 myelofibrosis (MF), including primary MF, post-PV MF, and post-essential thrombocythemia MF. The company recorded Jakafi sales of $183.3 million in the first quarter of 2016, up 58.9% year over year.

Meanwhile, Incyte, along with Eli Lilly and Company LLY, announced results from a pivotal long-term extension study (RA-BEYOND) on its rheumatoid arthritis (RA) candidate, baricitinib, which were presented at the Annual European Congress of Rheumatology.

The RA-BEYOND study evaluated patients who had completed the pivotal 24-week RA-BUILD study. Patients dosed with baricitinib in the RA-BUILD study continued to receive baricitinib at the dose of either 2 mg or 4 mg, while patients receiving placebo were switched to baricitinib 4 mg in the RA-BEYOND study.

Results from the study demonstrated superiority of baricitinib over placebo in preventing progressive radiographic structural joint damage in patients with RA at 24 weeks. These treatment benefits were maintained through 48 weeks.

Apart from RA-BEYOND, the company presented data from two other phase III studies – RA-BEGIN and RA-BEAM – on baricitinib. Data from the studies revealed that baricitinib resulted in significant improvements in pain, fatigue and the ability to perform daily activities compared to methotrexate and AbbVie Inc.’s ABBV Humira.

We remind investors that Eli Lilly submitted a regulatory application for the approval of oral once-daily baricitinib for the treatment of moderately-to-severely active RA in both the U.S. and the EU in the first quarter of the year.

According to the WHO Global Burden of Disease Report, more than 23 million people in the world suffer from RA. It has also been estimated that approximately three times as many women as men are affected by RA.

Incyte currently carries a Zacks Rank #3 (Hold). Bristol-Myers Squibb Company BMY is a better-ranked stock in the health care sector with a Zacks Rank #1 (Strong Buy).

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