- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Obinutuzumab Superior to Rituximab in Leukemia Study
Progression-free survival significantly improved (July 24)
Positive results have been announced from a phase III trial of obinutuzumab (GA101, Roche) in patients with untreated chronic lymphocytic leukemia (CLL).
The study met its primary efficacy endpoint — significant improvement of progression-free survival — compared with rituximab (Rituxan, Genentech/Biogen Idec) plus chlorambucil.
The new data will be submitted for consideration to the 55th Annual Meeting of the American Society of Hematology (ASH) in New Orleans, which will take place December 7–10, 2013.
Based on an earlier analysis of this phase III trial, a marketing application for obinutuzumab was submitted to the FDA in April 2013.
Obinutuzumab (GA101) is the first investigational type II, glycoengineered drug designed to target cells that have a certain marker (CD20) on their surfaces. Obinutuzumab attacks targeted cells both directly and together with the body’s immune system. The drug is currently being investigated in head-to-head phase III studies versus rituximab in patients with indolent non-Hodgkin lymphoma (NHL) and in patients with diffuse large B-cell lymphoma (DLBCL).
Source: Roche; July 23, 2013.