A new leukemia pill shows marked improvement in slowing and in some cases reversing the disease in patients who have run out of other options, according to a study that compared the drug with traditional treatment.
The study appears online in The New England Journal of Medicine and adds to evidence that ibrutinib (sold under the name Imbruvica) is extending and improving lives, said lead researcher Dr. John C. Byrd, director of hematology at the Ohio State University Comprehensive Cancer Center.
He is presenting the results at the American Society of Clinical Oncology meeting in Chicago this week.
Byrd and colleagues have seen the drug move through its infancy in the lab to Food and Drug Administration approval for mantle-cell leukemia (which is rare) and finally chronic lymphocytic leukemia, the most-common type of the disease in adults.
This study of 391 patients with CLL was primarily designed to look at progression-free survival. It found that after six months, 88 percent of those taking the pill had no sign of disease progression, compared with 65 percent of those on an infused immunotherapy treatment called ofatumumab.
After one year, 90 percent of those who took Imbruvica were alive compared with 81 percent of those on the other treatment. And in 43 percent of those taking the new pills, researchers could find no evidence of disease in their blood, compared with about 4 percent in the other group.
Taken three times a day and costing about $8,000 a month, Imbruvica is made by California-based Pharmacyclics. The company is working with patients whose insurance doesn’t cover the medication to make it more affordable, Byrd said.
The number of complications was similar in both groups, but more-severe side effects were higher in the Imbruvica group. Byrd said he was glad to learn that some especially concerning problems — life-threatening infections, in particular — were not more common. Imbruvica’s side effects include diarrhea, fatigue and nausea.
“We’re seeing many of our patients who are coming from all over the country ... that have been on this for two, three, four years coming back, and it’s very, very humbling because many of these people are individuals who had run out of options,” Byrd said.
“Some were in hospice. A lot of them were planning for the end because there really was nothing left.”
One big question that current research will determine is whether the pills make sense for newly diagnosed CLL patients, Byrd said.
Tim Hamburger, executive director of the central Ohio chapter of the Leukemia & Lymphoma Society, called the leukemia pill an “absolutely critical breakthrough.” The society helped fund Byrd’s research.
“There are only a few great treatment options. This has really opened up a lot of doors for folks,” Hamburger said. “I had breakfast with a CLL patient this morning.
“He’s at a point where he doesn’t need this therapy yet, but just to know it’s there, it’s available, gives great hope.”
Dr. Christopher George, an oncologist with OhioHealth Riverside Methodist Hospital, said in a statement that the drug is “another great advance” in caring for patients with leukemia.
By Misti Crane - The Columbus Dispatch, Ohio (MCT)
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