New Roche leukaemia drug beats rival
pharmafile | July 24, 2013 | News story | Research and Development, Sales and Marketing | Rituxan, Roche, leukaemia, obinutuzumab
Roche’s next generation leukaemia drug obinutuzumab has beaten the firm’s ageing blood cancer medicine Rituxan in a late-stage trial.
The drug, also known as GA101, delayed disease progression longer than Rituxan – also known as MabThera – in people with one of the most common forms of blood cancer.
The Phase III CLL11 study showed GA101 plus chlorambucil, a chemotherapy agent, was superior to MabThera/Rituxan plus chlorambucil in helping people with previously untreated chronic lymphocytic leukaemia live longer without their disease worsening.
The drug is currently undergoing an accelerated review by the FDA and a normal appraisal by the EMA. Roche submitted its medicine to both regulators in April this year.
In the US GA101 is being developed and will be commercialised in collaboration with Biogen Idec.
Roche is hoping its new medicine, if approved, will help fend off generic rivals for the $7 billion a year Rituxan, as the drug begins to lose its patent protection in Europe before 2014.
“The positive final results from the CLL11 study show the promise that GA101 could hold for people with CLL,” said Hal Barron, Roche’s chief medical officer.
“It is important to explore the potential of this medicine in other types of blood cancer, and our broad development program includes studies in aggressive and indolent lymphoma that compare GA101 with MabThera/Rituxan.”
GA101 is the first type 2 anti-CD20 medicine that is ‘glycoengineered’, which means specific sugar molecules in GA101 were modified to change its interaction with the body’s immune cells.
This modification creates a unique antibody that is designed to act as an immunotherapy, engaging the patient’s own immune system to help attack the cancerous cells; in addition, GA101 binds to CD20 with the aim of inducing direct cell death.
The drug is also currently being investigated in a large clinical programme, including multiple head-to-head Phase III studies versus MabThera/Rituxan in indolent non-Hodgkin lymphoma and diffuse large B-cell lymphoma.
Ben Adams
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