Ibrutinib surpasses ofatumumab as a second line therapy for treating CLL

Ibrutinib surpasses ofatumumab as a second line therapy for treating CLL -

In a comparison of head-to-head two FDA approved drugs for the treatment of diseases chronic lymphocytic leukemia relapse (CLL), Ibrutinib significantly outperformed ofatumumab as a second line therapy, according to a multicenter study published in the interim 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 progressive 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 4580 died of the disease in 2013.

in the current phase 3 trial, patients were randomized to receive once daily oral or Ibrutinib anti- CD20 ofatumumab, part of the drug considered to the current standard of care for CLL.

Of the 391 patients enrolled in 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 extended progression-free survival as second-line therapy for CLL before anything else is used.

"In the median follow-up, 86 percent of patients on Ibrutinib had a durable response and treatment with minimal side effects continue. This is remarkable, especially considering that standard CLL therapies generally produce a rate of 35-40 percent response, "said John C. Byrd, MD, principal investigator of the study and director of the hematology division at the Cancer Center of Ohio State University Comprehensive - Arthur G. James Cancer Hospital and Richard J. Solove research Institute (OSUCCC -. James)

at six months, 83 percent of patients treated with Ibrutinib experienced progression-free survival compared to 49 percent of patients on ofatumumab.

"Ibrutinib significantly prolongs progression-free survival, resulting in a reduction of 78 percent in the risk of disease progression or death in patients treated with ofatumumab compared to Ibrutinib," Byrd added. "We observed similar results for progression-free survival regardless of age, clinical stage or unique factors such as genetic mutation status."

In 2013, Byrd and his team reported the results of a phase 1b / 2 study of 85 patients with CLL patients relapsed on Ibrutinib in the New England Journal of Medicine. Based on the positive early response rates, the data monitoring committee recommended patients be given the opportunity to spend Ibrutinib arm of the study. At that time, 29 percent of patients with confirmed progression of the disease on ofatumumab Ibrutinib crossed the arm of the study.

At 12 months, the overall survival rate for patients treated with Ibrutinib was 0 percent compared to 81 percent in the ofatumumab arm. In addition, 43 percent of patients on Ibrutinib achieved partial response to treatment against only 4 percent of patients receiving ofatumumab.

"There is no doubt that Ibrutinib far surpasses the therapies we have for existing CLL, and we are delighted to see this drug improve outcomes for patients who were once considered incurable," Byrd said .