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.
Rituxan, discovered by Biogen Idec, first received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. It was approved in the European Union under the trade name MabThera in June 1998.INDICATIONS Rituxan ® (Rituximab) is indicated for the treatment of patients with:
- Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
- Previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to Rituxan in combination with chemotherapy, as single-agent maintenance therapy
- Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after first-line CVP chemotherapy
- Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens
- Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)
Patients should tell their doctor about any side effect that bothers them or that does not go away. These are not all of the possible side effects with Rituxan.Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch . Patients and caregivers may also report side effects to Genentech at (888) 835-2555. Patients should read the Rituxan Full Prescribing Information including Boxed WARNINGS, and the Medication Guide at http://www.rituxan.com. About Genentech Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.