Consistent Progression-Free Survival Benefit in Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Patients Treated with Ibrutinib

Researchers reported at the annual American Society of Clinical Oncology meeting in Chicago that chronic lymphoid leukemia (CLL) patients treated with Imbruvica™ (ibrutinib) continued to show improved survival when compared to those treated with Arzerra® (ofatumumab).1

About CLL

CLL, a subtype of non-Hodgkin Lymphoma (NHL), is one of the most common forms of leukemia in adults.2 CLL commonly arises from B cells, a type of white blood cell (lymphocyte) that originates in the bone marrow. CLL mainly affects older adults with a slightly higher risk in men than in women.2 There are approximately 115,000 patients in the U.S. with CLL, with more than 20,000 estimated new cases each year.2 SLL is similar to CLL and affects the same lymphocytes; the only difference between the two is the location where the cancer primarily occurs.2

About Imbruvica

Imbruvica was one of the first therapies to receive U.S. approval after having received the FDA’s Breakthrough Therapy Designation. Imbruvica works by blocking a specific protein called Bruton’s tyrosine kinase (BTK). The BTK protein transmits important signals that tell B cells to mature and produce antibodies and is needed by specific cancer cells to multiply and spread. Imbruvica targets and blocks BTK, inhibiting cancer cell survival and spread.

In the current trial one group of CLL patients was treated with the other with Arzerra. Progression-free survival (time of was the primary endpoint; secondary endpoints included overall survival and overall response rate.

As initially reported at six months, the Imbruvica group had a progression-free survival of 88% versus 65% for the Arzerra group. In terms of overall survival at 12 months, the Imbruvica patients had a rate of 90%, whereas the Arzerra group was at 81%.3  Because the Imbruvica group showed a significant advantage in progression-free survival at the interim point the trial was halted and Arzerra patients were crossed over to the Imbruvica treatment.  Additional follow-up data from the trial show a 59 percent progression-free survival at three years.   The overall response rate is 91 percent and complete response rates are increasing with longer follow-up

These findings demonstrated the continued benefit of imbruvica in previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma,” said John C. Byrd, M.D., Distinguished University Professor at the Ohio State University Comprehensive Cancer Center and lead investigator of the study.   “Importantly, with long-term follow up, many patients receiving imbruvica had a deepening of responses and continued improvement in progression-free survival. This study confirms imbruvica as a major therapeutic option for chronic lymphocytic leukemia/small lymphocytic lymphoma patients.”

  1. Abstract #7510: Long-Term Efficacy and Safety with Ibrutinib (ibr) In Previously Treated Chronic Lymphocytic Leukemia: Up to Four Years Follow-Up of The RESONATE Study (Poster Board: #272)
  2. American Cancer Society. What are the key statistics for chronic lymphocytic leukemia? Available from: http://www.cancer.org/cancer/leukemia-chroniclymphocyticcll/detailedguide/leukemia-chronic-lymphocytic-key-statistics. Accessed May 2017.
  3. http://news.cancerconnect.com/imbruvica-found-to-extend-survival-in-cll-patients/

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