Treating Indolent Non-Hodgkin's Lymphoma (NHL) with MabThera in combination with chemotherapy prolongs patient survival, according to the study presented at the annual meeting of the American Society of Haematology (ASH).
The study compared MabThera in combination with chemotherapy (R-MCP1) vs. chemotherapy alone (MCP2), as first-line treatment for patients suffering from indolent NHL. In both arms, patients responding to this treatment received interferon maintenance therapy until progression. It was found that at 2 years more patients receiving MabThera survived compared to patients receiving chemotherapy alone.
"This study is a major clinical breakthrough in the treatment of indolent lymphoma as until now no standard treatment has been able to prolong patients' lives," said Dr. Michael Herold, head of Haematology and Oncology at HELIOS Klinikum Erfurt, Germany.
"With this data we are once again seeing that MabThera may alter the natural history of indolent NHL," commented William M. Burns, Head of Roche's Pharmaceuticals Division. "After the wealth of impressive survival data in aggressive NHL, it is rewarding to observe that indolent NHL patients can also live longer when treated with MabThera. In addition, the latest data reinforces our label in first-line treatment of indolent NHL which was approved in Europe this year," he added.
According to a Roche release, the second trial, also presented at ASH, reinforces that MabThera should be part of the standard treatment for indolent NHL. This data shows that patients who continue to take MabThera therapy for two years following initial treatment gain, on average, two years without the disease progressing (progression free survival) over those who did not continue therapy (median progression free survival 38 months with maintenance treatment versus 15 months without).
In this international study3, conducted by the European Organization for the Research and Treatment of Cancer (EORTC), relapsed indolent NHL patients who responded to an initial phase of the trial, were randomly assigned to continue MabThera treatment every three months for two years (maintenance therapy), or no further treatment.
Non-Hodgkin's lymphoma affects 1.5 million people worldwide. Indolent NHL, representing about 45 per cent of NHL patients, is a slow developing but fatal cancer of the lymphatic system. Indolent NHL patients suffer from multiple relapses intermittent with periods of symptom free existence (remission). NHL is one of the fastest growing cancers and has grown in incidence by 80 per cent since the early 1970s.
MabThera is a therapeutic antibody that binds to a particular protein - the CD20 antigen - on the surface of normal and malignant B-cells. It then recruits the body's natural defences to attack and kill the marked B-cells.
Genentech and Biogen Idec co-market MabThera in the United States, and Roche markets MabThera in the rest of the world, except Japan, where MabThera is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.