Roche has filed obinutuzumab on both sides of the Atlantic to treat chronic lymphocytic leukaemia.
The submissions are based on data from the first results from a Phase III trial which compared the combination of obinutuzumab or Roche and partner Biogen Idec's blockbuster MabThera/Rituxan (rituximab) plus the chemotherapy chlorambucil. Combined with the latter, obinutuzumab demonstrated an 86% reduction in the risk of disease progression, relapse or death.
Additionally, the length of time during which people lived without their disease worsening (median progression-free survival) was more than doubled (23 months compared to 10.9 months) when compared to chlorambucil alone. The full data, including the comparison of MabThera/Rituxan plus chlorambucil with chlorambucil alone will be presented at the American Society of Clinical Oncology in Chicago next month.
The drug, also known as GA101, is the first type II anti-CD20 medicine that is glycoengineered, Roche says. This means that specific sugar molecules were modified to change its interaction with the body’s immune cells, thus helping the immune system remove cancer cells from the body. In addition, GA101 binds to CD20 with the aim of killing cancerous cells directly.
Marketing applications have been submitted to the European Medicines Association and the US Food and Drug Administration and the latter has granted obinutuzumab ‘breakthrough therapy designation’.