Investor Update
Basel, 10 December 2008
MabThera maintenance therapy in lymphoma patients stops cancer coming back for nearly three times as long as chemotherapy alone
Long-term phase III study confirms positive impact of MabThera maintenance therapy for patients in remission with recurrent/resistant Non-Hodgkin’s Lymphoma
New data presented at the 50th Annual Meeting of the American Society of Hematology (ASH) confirm that patients with recurrent or resistant follicular non-Hodgkin’s lymphoma (NHL) receiving MabThera maintenance therapy live almost 2.5 years longer without their disease progressing (progression-free survival, PFS) than those not receiving maintenance treatment.
Six-year follow-up results from a study conducted by the European Organisation for Research and Treatment Cancer (EORTC) study group demonstrate that patients with recurrent or resistant follicular NHL who were given MabThera maintenance therapy after their initial treatment, live significantly longer without their disease coming back than those treated with chemotherapy alone (median PFS 3.7 years vs 1.3 years, p<0.0001, hazard ratio 0.55). The results also indicate that patients treated with MabThera in combination with chemotherapy experience better complete response rates compared to patients treated with chemotherapy alone (29% vs 16%, p=0.0001).
“These results show that MabThera maintenance therapy can help patients with follicular NHL return to their ‘normal’ daily activities by offering years of extra time between relapses”, said Professor Marinus van Oers of the University of Amsterdam and lead investigator of the study. “This is an important advance in the treatment of this still incurable form of NHL that will be welcomed by patients and physicians alike.”
NHL affects one million people worldwide. Follicular NHL is a slow developing but serious cancer of the lymphatic system. It is currently considered incurable. NHL is one of the fastest growing cancers and has raised in incidence by 80% since the early 1970s.
About the study
EORTC 20981 is a randomized phase III study designed to evaluate the role of MabThera in the treatment of patients with recurrent or resistant follicular NHL during the induction and maintenance phases. In 2005, an analysis of the results showed that addition of MabThera/Rituxan (R) to the chemotherapy (CHOP1) induction regimen yielded increased overall and complete response rates, and that R maintenance strongly improved median progression free survival (PFS), both after induction with CHOP and R-CHOP, and overall survival (van Oers et al Blood 2006;108:3295). At that time, the median follow-up for the maintenance phase was 33 months. Now, the long-term outcome of maintenance treatment with a median follow-up of 6 years from start of maintenance has been reported. Study enrollment was as follows: 465 patients during the induction phase (234 R-CHOP; 231 CHOP) and 334 patients during the maintenance phase (167 R; 167 observation). The results show that patients treated with MabThera/Rituxan and CHOP induction therapy experience better complete response rates compared to patients treated with CHOP alone (29% vs 16%, p=0.0001). In addition, the results show that patients treated with MabThera/Rituxan during the maintenance phase experience improved PFS compared to patients observed (median 3.7 years vs 1.3 years, p<0.0001, hazard ratio 0.55). MabThera maintenance was also associated with a significant increase in grade 3/4 infections (9.7 % vs 2.4 %). Only 4% of patients had to discontinue maintenance therapy because of toxicity (mostly recurrent infections).
1) CHOP = cyclophosphamide, doxorubicin, vincristine and prednisolone
About MabThera
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. Stem cells (B-cell progenitors) in bone marrow lack the CD20-antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.
MabThera is indicated for the treatment of patients with stage III and IV follicular non-Hodgkin’s Lymphoma and patients with CD20-positive diffuse large B cell non-Hodgkin’s lymphoma. MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies. MabThera is known as Rituxan in the United States, Japan and Canada. To date, patients have received more than 1 million treatments with MabThera worldwide.
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.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at www.roche.com.
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