Roche's rituximab boosts PFS in CLL

Swiss drug major Roche's MabThera (rituximab) increases the time patients with the most common form of adult leukemia survive without their cancer progressing, according to results from a pivotal Phase III study in the first-line treatment of chronic lymphocytic leukemia

The pivotal CLL8 trial, initiated by the German CLL study group, successfully met its primary endpoint, by showing that patients treated with MabThera, which is sold as Rituxan in the USA, in combination with the current standard chemotherapy, achieved a significant improvement in progression-free survival, compared to those on chemotherapy alone. "The outcome of this trial represents an important advance in the treatment of this life-threatening disease, where there is currently a high unmet medical need," said William Burns, chief executive of Roche's pharmaceuticals division. "That the study reached its primary endpoint almost a year ahead of schedule indicates the important role MabThera will have in the treatment of CLL," he added.

According to Roche, this study will form the basis of the regulatory filing in the European Union later in the year to extend the use of MabThera for first-line CLL. Data from this trial will also be submitted for presentation at upcoming international scientific meetings. CLL is the most common type of leukemia in adults, accounting for approximately 25%-30% of all forms of the disease. Incidence of CLL in western countries is around two to four per 100,000, and is twice as common in men as in women. It mainly affects the elderly with 95% of patients diagnosed after the age of 55.