Incyte Plunges on Halted Colorectal Cancer Study
January 28, 2016
By Alex Keown, BioSpace.com Breaking News Staff
WILMINGTON, Del. – Incyte Corporation ’s has dropped more than 10 percent following the company’s decision to call an early halt to a Phase II trial studying the use of its blood cancer drug Jakafi for the treatment of metastatic colorectal cancer.
The decision to stop the sub-study was made after an interim analysis of the high C-reactive protein (CRP) subgroup demonstrated that ruxolitinib (Jakafi) plus Bayer AG ’s regorafenib did not show a sufficient level of efficacy to warrant continuation, the company said in a statement this morning. Steven Stein, Incyte’s chief medical officer, called the interim analysis disappointing.
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration (FDA) 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 not approved anywhere in the world as treatment for metastatic colorectal cancer.
Data from a trial studying Jakafi’s effectiveness on pancreatic cancer is expected next year. 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.
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.
Metastic colorectal cancer occurs when cancer cells break away from a tumor formed in the colon or rectum and spread to other parts of your body through the blood or lymphatic system to create new tumors. Colorectal cancer is the third most common non-skin cancer in men and women in the U.S., according to the National Cancer Institute. While still the second leading cause of cancer-related death in the U.S., over the past 10 years the number of colorectal cancer cases and related deaths have decreased, due in part to screenings, such as colonoscopies, according to the U.S. Food and Drug Administration. In September, the FDA approved Princeton, N.J.-based Taiho Oncology Inc.’s Lonsurf for patients with an advanced form of colorectal cancer who are no longer responding to other therapies.
News of the trial’s halt prompted analysts at Piper Jaffray to say the chances of Jakafi’s successful use for treating other cancers, including pancreatic, have increased, Reuters reported this morning.
“Jakafi for solid tumors is one of the key pillars to support Incyte's valuation and potential upside, so we are not surprised to see the after-market weakness," the analysts wrote in a note to clients, Reuters reported. “The last thing any company needs in the midst of the current biotech meltdown is a clinical trial setback.”
Incyte’s hit a low of $67.04per share this morning. In September, the stock reached a high of $131.47 per share, but has steadily declined since.