Roche's obinutuzumab significantly improves PFS in chronic lymphocytic leukemia

Swiss drug major Roche (ROG: SIX) says that the first stage of a Phase III study with its investigational cancer drug obinutuzumab met its primary endpoint and an additional futility analysis suggested that it could show superiority compared to the company’s currently marketed MabThera/Rituxan (rituximab) in first line chronic lymphatic leukemia (CLL).

Cancer and rheumatoid arthritis drug MabThera generated sales last year of 6.7 billion Swiss francs ($7.4 billion) but faces patent expiries in Europe from November this year and in 2018 the USA, where it is sold as Rituxan

This Phase III randomized study investigated the efficacy and safety profile of obinutuzumab (GA101) plus chlorambucil, a chemotherapy, compared with chlorambucil alone in people with previously untreated CLL. An improvement in progression-free survival (PFS) was achieved: GA101 plus chlorambucil significantly reduced the risk of disease worsening or death compared to chlorambucil alone.