Incyte Corporation (NASDAQ:INCY) announced its decision to discontinue the Phase 3 study (JANUS 1) of ruxolitinib or placebo in combination with capecitabine for the second-line treatment of patients with advanced or metastatic pancreatic cancer. The decision to stop the study was made after a planned interim analysis of JANUS 1 demonstrated that ruxolitinib plus capecitabine did not show a sufficient level of efficacy to warrant continuation.
Following these results, and the previously announced interim analysis of the Phase 2 sub-study of ruxolitinib or placebo in combination with regorafinib in patients with metastatic colorectal cancer and high C-reactive protein (CRP), ongoing Incyte-sponsored trials of ruxolitinib in solid tumors will be discontinued, including the Phase 3 JANUS 2 study in pancreatic cancer, the Phase 2 sub-study in patients with metastatic colorectal cancer and low CRP and the Phase 2 studies in breast and lung cancer. Incyte’s dose finding study of INCB39110 (a selective JAK1 inhibitor) as first-line treatment for metastatic pancreatic cancer, will also be discontinued. Incyte will work with investigators to appropriately conclude these studies in a manner consistent with the best interest of each patient. Data from these studies will be analyzed and shared with the scientific community over the coming months.
Ongoing studies of ruxolitinib and selective JAK1 inhibitors in hematology indications will continue. Ongoing studies of selective JAK1 inhibition in solid tumor indications that are based on different hypotheses will also continue. These include a series of studies evaluating INCB39110 in combination with either pembrolizumab (anti-PD-1 antibody), epacadostat (Incyte’s IDO1 inhibitor), or INCB50465 (Incyte’s PI3Kδ inhibitor) to assess the therapeutic utility of JAK1 inhibition based on its effects on the tumor microenvironment. Additionally, the potential impact of JAK1 inhibition on improving the benefit of targeted therapies will be investigated via a Phase 1/2 study of INCB39110 plus osimertinib, AstraZeneca’s next generation EGFR inhibitor.
“The hypothesis to evaluate the therapeutic utility of JAK inhibition in patients with solid tumors and high levels of systemic inflammation was initially supported by a subgroup analysis of the randomized, double-blind Phase 2 RECAP study, which suggested a survival benefit in patients with high levels of CRP. As a result, we and the broader scientific community believed further study in pancreatic cancer and other solid tumors with evidence of systemic inflammation was warranted. Unfortunately, the larger studies did not confirm this hypothesis,” said Rich Levy, M.D., Chief Drug Development Officer of Incyte. “Moving forward, we remain focused on our strategy to invest in innovation and in our broad development portfolio, as we seek to deliver new medicines to patients with cancer and other diseases.” (Original Source)
Shares of Incyte closed yesterday at $72.31, down $-1.26 or -1.71%. INCY has a 1-year high of $133.62 and a 1-year low of $64.51. The stock’s 50-day moving average is $85.20 and its 200-day moving average is $105.59.
On the ratings front, Incyte has been the subject of a number of recent research reports. In a report released yesterday, Leerink Swann analyst Michael Schmidt reiterated a Buy rating on INCY. Separately, on January 28, Oppenheimer’s Christopher Marai reiterated a Buy rating on the stock and has a price target of $129.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Michael Schmidt and Christopher Marai have a total average return of -5.2% and 7.6% respectively. Schmidt has a success rate of 42.2% and is ranked #2816 out of 3569 analysts, while Marai has a success rate of 46.8% and is ranked #163.
The street is mostly Bullish on INCY stock. Out of 9 analysts who cover the stock, 9 suggest a Buy rating . The 12-month average price target assigned to the stock is $126.25, which represents a potential upside of 74.6% from where the stock is currently trading.
Incyte Corp is a biopharmaceutical company. It discovers, develops and commercializes proprietary small molecule drugs to treat serious unmet medical needs, mainly in oncology.