Incyte Corporation (NASDAQ:INCY) announces five-year data from the Phase 3 COMFORT-I study evaluating the long-term safety and efficacy of Jakafi® (ruxolitinib) in patients with intermediate-2 or high-risk myelofibrosis (MF). These follow-up results showed an overall survival (OS) benefit among patients treated with ruxolitinib with a 31 percent reduction in the risk of death (HR=0.69; 95% CI: 0.50, 0.96; P=0.025) compared to patients randomized to placebo. Because the majority of patients on the placebo arm crossed over to receive ruxolitinib therapy (median 41.1 weeks after randomization), these data suggest that earlier treatment with ruxolitinib may be associated with improved long-term survival in patients with intermediate-2 or high-risk MF.
Additionally, over the five-year period, 59 percent (92/155) of patients who continued on treatment with ruxolitinib achieved at least a 35 percent reduction in spleen volume at any given time. The median duration of spleen response was 168.3 weeks. The mean spleen volume reduction from baseline at five years was 37.6 percent for patients who continued on treatment with ruxolitinib. After week 24, hemoglobin and platelet count remained stable through 5 years.
“Nearly, five years after the launch of Jakafi for the treatment of intermediate and high-risk MF, these findings provide important insight into the treatment’s long-term clinical benefits,” said Steven Stein, M.D., Incyte’s Chief Medical Officer. “The overall survival benefit observed in the COMFORT-I study, along with sustained reductions in spleen volume, are meaningful for patients with this rare disease who often experience significant, debilitating symptoms, and even mortality, as a result of their disease.”
These data are scheduled for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2016 taking place June 3–7, 2016 in Chicago, Illinois.
“Previous findings from this study and overall survival trends reinforce the benefits of long-term treatment with ruxolitinib in patients with intermediate and high-risk MF. Achieving outcomes such as reduction in spleen volume is critical to the successful management of patients with this chronic and debilitating disease,” said Ruben A. Mesa, M.D., FACP, Chair, Division of Hematology & Medical Oncology, Deputy Director, Mayo Clinic Cancer Center, Chair, Arizona Cancer Coalition, and Professor of Medicine.
Results from the COMFORT-I Study
COMFORT-I, a randomized (1:1), double-blind, placebo-controlled Phase 3 study, compared the efficacy and safety of ruxolitinib to placebo in 309 patients with intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.
Of the 155 patients randomized to ruxolitinib, 28 percent of patients were still on treatment at the time of this analysis (median follow-up 268 weeks). Of the 111 patients originally randomized to the placebo arm who crossed over to ruxolitinib (median 41.1 weeks after randomization), 25 percent remained on treatment at the time of this analysis (median follow-up 268 weeks).
Overall, 69 (45%) and 82 (53%) deaths were reported in the ruxolitinib and placebo arms, respectively. Median OS has not been reached for patients randomized to receive ruxolitinib.
Adverse events (AEs) were consistent with those reported in previous studies of ruxolitinib and there was no increase in the incidence of AEs with longer exposure to treatment.
COMFORT-I (Abstract #7012) is scheduled for presentation by Dr. Mesa on Monday, June 6, 2016, 8:00–11:30 a.m., E354b Hall A. (Original Source)
Shares of Incyte closed last Friday at $84.96, down $2.75 or -3.14%. INCY has a 1-year high of $133.62 and a 1-year low of $55. The stock’s 50-day moving average is $76.77 and its 200-day moving average is $83.25.
On the ratings front, Incyte has been the subject of a number of recent research reports. In a report issued on May 24, Jefferies Co. analyst Brian Abrahams reiterated a Buy rating on INCY, with a price target of $88, which represents a slight upside potential from current levels. Separately, on May 19, Morgan Stanley’s Andrew Berens reiterated a Buy rating on the stock and has a price target of $85.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Brian Abrahams and Andrew Berens have a total average return of 12.9% and 11.0% respectively. Abrahams has a success rate of 67.0% and is ranked #170 out of 3894 analysts, while Berens has a success rate of 62.5% and is ranked #518.
Overall, 8 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $91.40 which is 7.6% above where the stock closed last Friday.
Incyte Corp. is a biopharmaceutical company, which focuses on the discovery, development, development, formulation, manufacturing and commercialization of proprietary therapeutics to treat serious unmet medical needs, primarily in oncology. Its product, Jakafi, a JAK1 and JAK2 inhibitor, is currently approved in the U.S. for the treatment of intermediate or high-risk myelofibrosis and is in development as a potential treatment for other cancers.