Columbus, Ohio – In a head-to-head
comparison of two Food and Drug Administration-approved drugs for the treatment
of relapsed chronic lymphocytic leukemia (CLL), ibrutinib significantly
outperformed ofatumumab as a second-line therapy, according to a multicenter interim
study published in the OnLine First edition of the New England Journal of Medicine. Ibrutinib (Imbruvica) is the first
drug designed to target Bruton’s tyrosine kinase (BTK), a protein essential for
CLL-cell survival and proliferation. CLL, the most common form of leukemia,
causes a gradual increase in white blood cells called B lymphocytes, or B
cells. The National Cancer Institute estimates that 15,680 Americans were
diagnosed with CLL and 4,580 died from the disease in 2013.
the current phase 3 trial, patients were randomized to receive once-a-day oral
ibrutinib or the anti-CD20 antibody ofatumumab, a drug considered part of the
current standard of care for CLL.
the 391 patients enrolled to the phase 3 study, 195 were randomized to ibrutinib
and 196 to ofatumumab. Median follow-up was 9.4 months and showed that
ibrutinib significantly lengthened progression-free survival as a second-line
therapy for CLL before anything else is used.
median follow-up, 86 percent of patients on ibrutinib had durable response and
were continuing treatment with minimal side effects. This is remarkable,
especially considering that standard CLL therapies typically produce a 35-40
percent response rate,” says John
C. Byrd, MD, principal investigator of the study and hematology
division director at The Ohio State University Comprehensive Cancer Center –
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James.)
six months, 83 percent of patients treated with ibrutinib experienced
progression-free survival compared to 49 percent of patients on
rutinib significantly prolonged
progression-free survival, resulting in a 78 percent reduction in the risk of
disease progression or death in patients treated with ibrutinib compared with
ofatumumab,” adds Byrd. “We observed similar progression-free survival results
regardless of age, clinical stage or unique factors such as genetic mutation
Byrd and his team reported findings from a phase 1b/2 study of 85 patients with
relapsed CLL patients on ibrutinib in the New
England Journal of Medicine. Based
on positive early response rates, the Data Monitoring Committee recommended
patients be given option to switch to the ibrutinib arm of the study. At that
time, 29 percent of patients with confirmed disease progression on ofatumumab
crossed over to the ibrutinib arm of the study.
12 months, the overall survival rate among patients treated with ibrutinib was
90 percent compared to 81 percent in ofatumumab arm. Additionally, 43 percent of patients on
ibrutinib achieved partial response to treatment compared with just 4 percent
of patients receiving ofatumumab.
is no question that ibrutinib far outperforms existing therapies we have for
CLL, and we’re excited to see this drug improving the outcome for patients who
were once considered incurable,” says Byrd.
3 studies are currently underway at The OSUCCC – James and affiliated cancer
centers to determine whether ibrutinib is effective as a first-line therapy in
CLL, and in other blood cancer treatment challenges such as reducing graft
versus host disease in bone marrow transplant patients.
research was funded with support from the Four Winds Foundation, D. Warren Brown
Foundation, Mr. and Mrs. Michael Thomas, Mr. and Mrs. Al Lipkin, Harry T.
Mangurian Jr. Foundation, Sullivan CLL Research Foundation, the National
Institutes of Health (P50 CA140158, RO1 CA177292), Leukemia & Lymphoma
Society and Janssen Research and Development. Byrd has no financial interest in
Janssen, manufacturer of the drug Imbruvica.
The OSUCCC – James
Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer
Hospital and Richard J. Solove Research Institute strives to create a
cancer-free world by integrating scientific research with excellence in
education and patient-centered care, a strategy that leads to better methods of
prevention, detection and treatment. Ohio State is one of only 41 National
Cancer Institute (NCI)-designated Comprehensive Cancer Centers and one of only
four in the United States funded by the NCI to conduct both phase I and phase
II clinical trials. The NCI recently rated Ohio State’s cancer program as “exceptional,”
the highest rating given by NCI survey teams. As the cancer program’s 228-bed
adult patient-care component, The James is one of the top cancer hospitals in
the nation as ranked by U.S.News &
Media Contact: Amanda J.
Harper, Director of Media Relations, The OSUCCC–James, 614-685-5420 (direct), 614-293-3737
(central media line) or Amanda.Harper2@osumc.edu