A Phase 3 clinical study found that Ibrutinib performed better compared to Ofatumumab, a drug approved by the U.S. Food and Drug Administration in 2009, in treating patients with chronic lymphocytic leukemia (CLL).
Ofatumumab, a drug made by GlaxoSmithKline under the brand name Arzerra, was approved by the FDA for patients with CLL whose cancer is no longer controlled by chemotherapy. Ibrutinib, manufactured by Johnson & Johnson and Pharmacyclics under brand name Imbruvica, is an FDA-approved treatment for patients with rare, aggressive type of blood cancer called mantle cell lymphoma (MCL).
Ibrutinib is currently being tested for possible expanded use of the drug for CLL patients. Researchers from Ohio State University's Wexner Medical Center released the results of their Phase 3 clinical trial on Saturday showing that the drug performed better than Ofutumumab by 34 percent.
For the test, the research team recruited 391 patients with CLL; 195 took Ibrutinib while 196 took ofatumumab once a day for an average of nine months. On the sixth month of the study, the researchers noted that 83 percent of those who took ibrutinib did not experience relapse while it was only 49 percent for the other group. Continuous use of ibrutinib to up to 12 months could reduce relapse incidents to up to 90 percent.
"At 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," said John C. Byrd, MD, lead researcher of the study and hematology division director at The Ohio State University Comprehensive Cancer Center, in a news release.
In addition, the test concluded that CLL patients who took Ibrutinib cut their risk of relapse or death by 78 percent compared to the other group. The results remained consistent even after including other factors such as age, gender, stage of disease and genes.
"There 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," added Byrd.
Details of the study results were published in the May 30 issue of New England Journal of Medicine.
