Clinical trials show the drug produces ‘high rate
of durable remissions’ in leukemia patients
By Jay Hansen
There’s a figurative journey taken by those fighting cancer. For many of them, there’s also a literal one.
Donna Cann’s journey was an 18-hour roundtrip drive taken with her husband, Harry. Wally Yocum came from Marietta, Ohio, starting his trip at 4:30 a.m. and arriving home later that night after dinner. Midge Lipkin’s journey consisted of a long drive and two flights, often taken alone.
While these trips varied, Cann, Yocum and Lipkin had a common destination. All were traveling to Columbus to participate in clinical trials of the drug ibrutinib at The Ohio State University Comprehensive Cancer Center – Arthur G. James Hospital and Solove Research Institute.
In February, the U.S. Food and Drug Administration expanded the approved use of ibrutinib to treat chronic lymphocytic leukemia, the most common form of leukemia. The drug, which goes by the product name Imbruvica, has produced exceptional results for patients participating in trials at OSUCCC – James. FDA approval means it will now be available to more of those fighting leukemia.
“I’m grateful that thousands of people are going to have the opportunity to have their lives saved by this,” Cann said. “I call it a miracle drug.”
Ohio State connection
Much of the clinical work and research done to bring ibrutinib to market was done at Ohio State under the leadership of John Byrd, director of the James Division of Hematology and professor of medicine. He said, “Our clinical studies consistently suggested that ibrutinib is a highly active oral therapeutic that produces a high rate of durable remissions.”
Yocum was among those who participated in the trial. He’d been diagnosed with leukemia on the day his grandson was born in 2008 and had already been through a round of chemotherapy and another clinical trial when he joined the ibrutinib trial in October 2011.
Two-and-a-half years later, Yocum remains in remission.
“Life expectancy for CLL was five years or less when I was diagnosed,” Yocum said. “It was frightening to hear that at the time; until that point I’d been about as healthy as you could be.
“To think back on where I was and what I went through in 2008, and to see where I am now is an amazing thing. For the last two years I’ve probably had fewer complaints than a normal, happy, healthy person.”
Two notable benefits of ibrutinib treatments are how quickly the drug produces results and that its side effects are relatively mild compared to other forms of treatment.
“Patient responses can last for many months, in part because they’re willing to remain on the drug since the side effects are very tolerable,” Byrd said.
Yocum found the side effects, “uncomfortable but not unbearable.” Cann agreed, and remains surprised with how quickly her symptoms subsided.
“The first week of treatment I had some enlarged lymph nodes in my abdominal area,” said Cann, who was diagnosed with CLL in 2006. “I joined the study and took three capsules on a Monday. By Wednesday there were noticeable improvements.
“I see myself as a grateful recipient of something wonderful.”
A caring environment
Lipkin has endured a long battle with leukemia. She was diagnosed 28 years ago but went 15 years without requiring treatment. When symptoms began to surface, Lipkin’s oncologists at the Dana-Farber Cancer Center in Boston started her on a chemotherapy regimen.
When Lipkin’s system became toxic from the chemo, she needed another solution. Doctors at Dana-Farber recommended Byrd and his team at the James.
“At first I said, ‘Columbus? Who does cancer work in Columbus?’” said Lipkin, whose father died of leukemia. “But I went and immediately was so impressed with Dr. Byrd. When I first met him he immediately made me comfortable. He talks at your level.
“When you go through something like this, you’re scared. You need warmth, enthusiasm and encouragement, and Dr. Byrd and his team had all of those things. They were wonderful people.”
Lipkin, Yocum and Cann all have similar things to say about Byrd and his team, sharing numerous stories about the positive reinforcement that helped them deal with the mental side of fighting cancer. They are all currently in remission and all thrilled to see ibrutinib now available to a larger group of patients.
Yocum has remained active in studying the disease and its effects. He has noted that in CLL online communities, the discussion about the disease is shifting.
“It used to be about where you could go to get these treatments and how they were working,” Yocum said. “It isn’t about how it is working any more. Now the discussion is about how it’s covered under insurance plans and how to get it.
“This will be a front-line treatment for leukemia. It’s pretty remarkable.”