There was more good news on Roche's 'breakthrough' leukaemia drug GA101 this morning, with trial data showing that it outperformed veteran drug MabThera (also sold as Rituxan) in a late-stage trial.
The Phase III CLL11 study has shown that GA101 (obinutuzumab) plus chemotherapy was better than the Swiss drug giant's MabThera at delaying disease progression in patients with previously untreated chronic lymphocytic leukaemia (CLL).
At a pre-planned interim analysis, an independent data monitoring committee concluded that the study had already met its primary endpoint showing that the GA101 regimen helped people live significantly longer without their disease worsening than the MabThera-based one.
Roche also noted that these final data were reached "well ahead of the target completion date in 2014 as a result of the magnitude of difference seen between the two study arms", and that it would submit the CLL11 study to the American Society of Haematology’s Annual Meeting in December.
GA101 is the first type II anti-CD20 medicine that is glycoengineered, a process by which specific sugar molecules are modified to change a drug's interaction with the body’s immune cells.
This modification creates a unique antibody designed to act as an immunotherapy, prompting the immune system to help attack the cancerous cells.
Earlier this month, US regulators said they would carry out an accelerated review of the drug, after having awarded it "breakthrough therapy" status back in May.