Roche reports encouraging results from Phase III leukemia trial

The pivotal REACH trial successfully met its primary endpoint by showing that patients treated with MabThera in combination with the current standard chemotherapy were able to significantly extend the amount of time they lived without their disease progressing, compared to patients treated with chemotherapy alone. Preliminary analysis of the safety data is in line with previous trials.

The Reach study is a randomized international study that included 552 patients with chronic lymphocytic leukemia (CLL). It was conducted at 90 study sites across 18 countries. The study was set up to investigate whether treatment of patients with 2/3 relapsed or refractory CLL with MabThera in combination with chemotherapy (fludarabine and cyclophosphamide) was more beneficial than treatment with chemotherapy alone.

The primary endpoint of the study was to show an increase in terms of median progression-free survival. The data will be used for applying for approval for the use of MabThera in relapsed or refractory CLL with the relevant health authorities.

Genentech and Biogen Idec co-market MabThera in the US, and Roche markets MabThera in the rest of the world, except Japan, where MabThera is co-marketed by Chugai and Zenyaku Kogyo.

William Burns, CEO of pharmaceuticals division at Roche, said: “The positive results of the Reach study are very encouraging news for patients suffering from a disease that remains life-threatening and incurable. The outcome of this trial, together with the positive findings of the pivotal CLL8 trial in first-line CLL patients, clearly demonstrate the important role MabThera will have in the treatment of this devastating disease.”