February 11, 2016
By Alex Keown, BioSpace.com Breaking News Staff
WILMINGTON, Del. – Incyte Corporation ’s stock is down more than 20 percent this morning after the company announced it was halting its Phase III trial of its blood cancer drug Jakafi for the treatment of patients with advanced or metastatic pancreatic cancer.
The stock hit a morning low of $55 per share, down from its Wednesday closing price of $72.31 per share. This is the second big drop Incyte’s stock has had in less than a month. On Jan. 28, company stock dropped more than 10 percent following the company’s decision to call an early halt to a Phase II trial studying the use of Jakafi for the treatment of metastatic colorectal cancer.
Developing treatments for solid tumors has been pillar of Incyte’s future growth. Although Jakafi will not be studied for the treatment of solid tumors, Incyte has the drug candidate epacadostat in its pipeline for solid tumors.
“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,” Rich Levy, Incyte’s chief drug development officer, said in a statement.
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration for treatment of people with polycythemia vera (where the marrow makes too many red blood cells) who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF. Jakafi is expected to generate approximately $500 million in 2015. The success of that drug is driving the company, in part, to hire an additional 400 employees, which was announced in November. It is unknown if the halting of this trial will impact the company’s hiring.
Incyte’s decision to halt its Phase III trial was made after an interim analysis demonstrated that Jakafi (ruxolitinib) plus capecitabine did not show a sufficient level of efficacy to warrant continuation. The trial was aimed at treating patients who had failed or were intolerant of first-line chemotherapy. The primary objective of the study was to evaluate and compare the overall survival of patients treated with ruxolitinib in combination with capecitabine versus capecitabine alone.
With the halting of the two trials, Incyte said it was discontinuing ongoing Incyte-sponsored trials of Jakafi in solid tumors, which includes a Phase II sub-study in patients with metastatic colorectal cancer and low CRP and the Phase II studies in breast and lung cancer. Incyte said it will also discontinue its dose finding study of INCB39110 (a selective JAK1 inhibitor) as first-line treatment for metastatic pancreatic cancer.
Following the conclusion of the trials, Incyte said it will analyze and share the data from the studies. Jakafi and selective JAK1 inhibitors will continue to be studied for efficacy in hematology, the company said. Additionally, selective JAK1 inhibition in solid tumor indications that are based on different hypotheses will also continue, including studies evaluating INCB39110 in combination with either pembrolizumab (anti-PD-1 antibody, such as Merck ’s Keytruda), epacadostat (Incyte’s IDO1 inhibitor), or INCB50465 (Incyte’s PI3Kd inhibitor) to assess the therapeutic utility of JAK1 inhibition based on its effects on the tumor microenvironment, Incyte said in a statement. The company added it will also continue a Phase I/II study of INCB39110 plus Tagrisso (osimertinib), AstraZeneca ’s next generation EGFR inhibitor.
