Incyte (INCY) Reports Phase III Follow-Up Data For Jakafi
Zacks Investment Research | Dec 10, 2017 10:02PM ET
Incyte Corporation (NASDAQ:INCY) announced a new 208-week (4-year) follow-up data from the phase III RESPONSE study of Jakafi. The study compared the efficacy and safety of Jakafi with best available therapy (BAT (LON:BATS)) in patients with polycythemia vera (PV), who are resistant to or intolerant of hydroxyurea (HU).
The primary response was a composite endpoint of the proportion of patients, who achieved both hematocrit (Hct) control (defined as no phlebotomy eligibility from week 8 through week 32) and a spleen volume reduction of at least 35% from baseline at week 32. The study met the primary endpoint showing that Jakafi was superior to BAT at controlling hematocrit (Hct) and reducing spleen volume at week 32.
The data from this study showed that durable primary response to Jakafi in patients with PV who are resistant to or intolerant of HU and overall safety profile for Jafaki remained consistent with the 80-week RESPONSE data published earlier. In fact, the 80 week follow up from the RESPONSE study confirmed that among patients who initially responded to Jakafi treatment have probability of maintaining primary and hematocrit (Hct) responses for greater than 80 weeks was 92% and 89%, respectively. Thus confirming that Jakafi could be an effective long-term treatment option for patients with PV who are HU-resistant or intolerant.
So far this year, Incyte’s shares have declined 3.7%, as against the Zacks Investment Research
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