Following the recommendation by an independent Data Monitoring Committee (DMC), Gilead Sciences, Inc today announced that its Phase 3 clinical study evaluating Zydelig® (idelalisib) added to standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients will be unblinded early. The DMC recommendation is based upon a predefined interim analysis indicating a benefit in patients receiving Zydelig plus Treanda (bendamustine) and Rituxan (rituximab), compared to those receiving only Treanda and Rituxan. Detailed results from this study will be presented during the Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida, taking place December 5-8.
Chronic lymphocytic leukemia is the most common adult leukemia with over 15,000 new cases per year in the United States and almost 5,000 deaths. CLL is not a rapidly growing cancer, but the abnormal cells accumulate in blood, bone marrow, lymph nodes, and spleen, resulting in enlargement of these organs and decreased bone marrow and immune function. The FDA has approved several new treatment options for CLL in recent years including Gazyva (obinutuzumab), Imbruvica (ibrutinib), Arzerra (ofatumumab), and Zydelig. Researches will continue to evaluate the best way to use the medicines in order to improve the outcome of individuals diagnosed with CLL.
Zydelig is an oral inhibitor of phosphoinositide 3-kinase (PI3K) delta, a protein that plays a role in the activation, proliferation and viability of B cells, a critical component of the immune system. PI3K delta signaling is active in many B-cell leukemias and lymphomas by inhibiting the protein. Zydelig blocks several cellular signaling pathways that drive B-cell viability.
The study results to be presented at ASH are from a comparative trial designed to directly compare the safety and effectiveness of Zydelig added to Treanda, and Rituxan among 416 adult patients with previously treated CLL.
Reference: Zelenetz A, Robak T, Coiffier B, et al. LBA-5 Idelalisib plus bendamustine and rituxumab (BR) is superior to BR alone in patients with relapsed/refractory chronic lymphocytic leukemia: results of a phase 3 randomized double-blind placebo-controlled study.[Abstract] ASH 57th Annual Meeting & Exposition, Orlando FL, December 5-8, 2015. https://ash.confex.com/ash/2015/webprogram/Paper87420.html
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