Ohio State Research Played Significant Role in Ibrutinib Approval, Along With Pelotonia-Supported Clinical Trial
On her 70th birthday in June 2012, Judy Hileman, a Kansas native with a PhD in nursing, was diagnosed with chronic lymphocytic leukemia (CLL). After two chemotherapy regimens failed, Hileman’s condition worsened to ultra-high risk CLL, and her oncologists searched for clinical trials around the nation that might help her.
Hileman opted for a Pelotonia-funded phase II clinical trial at Ohio State of the drug ibrutinib.
Ibrutinib (Imbruvica®) is the first drug designed to target Bruton’s tyrosine kinase, a protein essential for CLL-cell survival and proliferation. CLL is the most common form of leukemia in the Western Hemisphere and is currently incurable.
The trial, directed by principal investigator Kami Maddocks, MD, will help identify whether ibrutinib works in high-risk patients like Hileman as well as it works in patients with better-risk disease. It will also help determine why some patients don’t respond for long to the drug.
Maddocks’ trial (OSU-11133) accepts patients with CLL/small lymphocytic leukemia (SLL) who have not responded to or who have relapsed after standard treatment. Open only at Ohio State, the trial is part of a larger body of research at Ohio State’s Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute (OSUCCC – James) that has shown ibrutinib has strong potential as a safe and effective agent for patients with CLL or mantle cell lymphoma (MCL).
The Ohio State studies played a significant role in the drug’s approval by the Food and Drug Administration (FDA) in February 2014 for patients with relapsed or refractory CLL. (In November 2013, the FDA approved ibrutinib for patients with relapsed or refractory MCL, as well.)
Much of the clinical and basic-science research that led to the CLL approval was conducted at the OSUCCC – James, in part using Pelotonia dollars.
And much of the Ohio State work was led by John C. Byrd, MD, who holds the D. Warren Brown Designated Chair in Cancer Research and directs the Division of Hematology at Ohio State. Other key leukemia team members include: Amy Johnson, PhD; Jason Dubovsky, PhD; Jeffrey Jones, MD, MPH; Joseph Flynn, DO, MPH; Jennifer Woyach, MD; Kristie Blum, MD; Michael Grever, MD; and Maddocks
“Our clinical studiesc onsistently suggested that ibrutinib is a highly active oral drug that produces a high rate of durable remissions in patients with relapsed and refractory (resistant to treatment) CLL,” says Byrd, who also co-leads theL eukemia Research Program at the OSUCCC – James. “Patient responses can last many months, partly because patients are willing to remain on the drug since the side effects are tolerable.”
Pelotonia funds have also indirectly supported clinical trials of ibrutinib through their allocation to the OSUCCC – James Clinical Trials Office, which oversees all cancer clinical trials at Ohio State.
Happily, Hileman did benefit from Maddocks’ trial. She began improving almost immediately upon taking ibrutinib. After 15 weeks her lab tests began to normalize, her energy returned, and she was able to “resume my normal life.” Hileman remains on the trial, taking three capsules daily. She returns to The James every three months for a check-up.
“Ibrutinib has changed so many lives,” she says. “One of the nurses told us they have never seen so many folks do so well on a clinical trial drug. For many patients, like me, that drug may be their last hope.”