About CLL11 (BO21004)
CLL11 is a Phase III, multicenter, open-label, randomized three-arm study investigating the safety and efficacy profile of GA101 plus chlorambucil compared to Rituxan plus chlorambucil or chlorambucil alone in nearly 800 previously untreated people with CLL and coexisting medical conditions. The study is conducted in close collaboration with the German CLL Study Group (DCLLSG). The primary endpoint of the study is PFS with secondary endpoints including overall response rate (ORR), overall survival (OS), disease free survival (DFS), molecular remission and safety profile.
About Hematological Malignancies
Hematological malignancies are cancers of the blood and include CLL, indolent NHL and diffuse large B-cell lymphoma (DLBCL). In 2013, it is expected that there will be nearly 19,020 annual deaths from NHL and nearly 4,580 annual deaths from CLL in the United States.The current standard of care in CD20-positive hematological malignancies is Rituxan in combination with chemotherapy or as a single agent. In addition to GA101, our pipeline of potential hematology medicines includes two antibody-drug conjugates (anti-CD79b [RG7596] and anti-CD22 [RG7593]), a small molecule BCL-2 inhibitor (RG7601) and a small molecule antagonist of MDM2 (RG7112). About Obinutuzumab (GA101) GA101 is Genentech’s most advanced investigational medicine in development for hematological malignancies (cancers which affect the blood, bone marrow and lymph nodes). GA101 targets CD20 proteins found on B-cells, and is designed to result in cell death. GA101 is the first glycoengineered, type 2 anti-CD20 monoclonal antibody in development for B-cell malignancies. GA101 is currently being investigated in multiple clinical trials, including head-to-head trials versus Rituxan. About Rituxan Rituxan is a therapeutic antibody that binds to a specific protein called CD20 found on the surface of cancerous and normal B-cells. In CLL, NHL and rheumatoid arthritis (RA), Rituxan works with the body's own immune system to eliminate marked CD20-positive B-cells. Stem cells (those cells that give rise to B-cells) in bone marrow do not have the CD20 protein. B-cells usually regenerate after Rituxan treatment and return to normal levels in about 12 months for most patients.