Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s Phase 3 study (Study 116) evaluating idelalisib in combination with rituximab in previously-treated chronic lymphocytic leukemia (CLL) patients who were not fit for chemotherapy was accepted for presentation during a late-breaking abstracts session at the Annual Meeting of the American Society of Hematology (ASH) in New Orleans (Abstract #LBA-6). Detailed results from the study will be presented at ASH on December 10, 2013.
CLL is a slow-growing cancer in which the bone marrow overproduces white blood cells, leaving less room in the blood and bone marrow for other types of blood cells. It is the most common leukemia in adults in the United States, occurring typically in older individuals, and it can lead to life-threatening complications, including serious infections and anemia. In 2013, there were an estimated 16,000 new CLL diagnoses in the United States and 4,500 deaths related to this cancer.
“Patients with relapsed CLL have limited treatment options and are often not able to tolerate chemotherapy,” said Richard R. Furman, MD, Richard A. Stratton Assistant Professor of Clinical Medicine, Division of Hematology/Oncology, Weill Cornell Medical Center / New York Presbyterian Hospital. “Based upon the results of this study demonstrating significant improvements in progression-free and overall survival, idelalisib represents an important addition to the armamentarium for patients living with this life-threatening disease.”
Study 116 was stopped early based on a pre-specified interim analysis performed by an external Data Monitoring Committee (DMC) showing a highly statistically significant effect on the primary endpoint of progression-free survival (PFS).Safety was in line with previous observations, and was largely consistent with advanced disease patients receiving CD20 antibody therapy. Additional details contained in the Study 116 abstract are available at www.hematology.org/2013abstracts. These data in CLL support Gilead’s plans for regulatory filings for idelalisib in the United States and European Union. On September 11, 2013, Gilead submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for idelalisib for the treatment of refractory indolent non-Hodgkin’s lymphoma (iNHL). Following Gilead’s NDA submission for iNHL, FDA granted idelalisib a Breakthrough Therapy designation for CLL in relapsed patients based on results from Study 116. Gilead is now engaging in a dialogue with the FDA regarding a regulatory filing in CLL. Gilead filed for approval in iNHL and CLL with the European Medicines Agency (EMA) on October 28, 2013.