Investor Update
Basel, 9 December 2008
First glyco-engineered and humanized monoclonal antibody in clinical trials could offer hope for difficult to treat lymphoma patients
Roche shows promising early results for its third-generation monoclonal antibody for CD20-positive hematological malignancies
Data presented for the first time today, at the 50th Annual Meeting of the American Society of Hematology (ASH), show that R7159/GA101, a new monoclonal anti-CD20 antibody in clinical development, could offer powerful benefits in treating patients with relapsed or refractory types of non-Hodgkin’s lymphoma (NHL) and other CD20-positive hematological malignancies, recognised as difficult-to-treat patient populations.
Results from a phase I/IIa study demonstrate that 67% of heavily pretreated patients (14 out of 21) with relapsed or refractory NHL or other CD20-positive hematological malignancies responded to treatment with R7159/GA101 monotherapy. Four patients were regarded as being in complete remission following treatment (19% complete response), 5 patients (24%) experienced a partial response and 5 patients (24%) were able to achieve a stabilisation of their disease. Responses have occurred at all dose levels. As well as demonstrating strong efficacy, the results also indicate that R7159/GA101 is well tolerated.
“There are undoubtedly excellent lymphoma treatments already in existence, but some patients still fail to be cured,” said Professor Gilles Salles, Centre Hospitalier Lyon-Sud, France and lead investigator of the study. “We need to continue to look to the future so that we can offer patients innovative treatments for every stage of lymphoma. R7159/ GA101 is the first in a new class of anti-CD20 antibodies to enter clinical trials and, so far, the results are really very encouraging indeed. We are eager to pursue clinical trials with R7159/GA101, as single agent or combined with chemotherapy, to further characterize its activity in B-cell lymphoma.”
This study, presented at ASH will be expanded to include further dosing schemes, and further clinical data is expected in 2009.
“Although R7159/GA101 is still in the early stages of development, we are excited by these data,” said Manfred Heinzer, Head of Roche Strategic Marketing. “MabThera has revolutionised the management of NHL, with over 1.5 million people treated with the drug to date and we hope that R7159/GA101 will provide another option for those patients requiring more therapeutic choices.”
About the study
The study is a phase I/IIa study designed to assess R7159/GA101, a novel antibody-dependent cytotoxicity (ADCC)-enhanced type II anti-CD20 antibody, in patients with CD20-positive malignant disease as a monotherapy. 21 patients, 20 of whom had previously been treated with MabThera (rituximab) for a median of 3 prior regimens, were enrolled in the study. Of these patients, 15 had follicular NHL, 3 had Mantle cell lymphoma, 1 had diffuse large B-cell lymphoma, 1 had lymphocytic/lymphoplasmacytoid lymphoma and 1 had Waldenström’s macroglobulinaemia. Doses tested ranged from 50 to 2000 milligrams. The endpoints included safety and tolerability, dose-limiting toxicity, pharmacokinetics and the phase II-dose of R7159/GA101 given as monotherapy. The phase II portion in NHL is now recruiting.
A dose escalation in CLL patients has been performed separately in this study and will be reported later. The safety profile of R7159/GA101 has been shown to be very similar to that of rituximab.
About R7159/GA101
R7159/GA101 is the first humanised and glyco-engineered monoclonal anti-CD20 antibody entering clinical trials. It is a novel ADCC-enhanced type II anti-CD20 antibody that has shown a similar safety profile to rituximab and promising efficacy in patients with CD20-positive malignant disease. Previous preclinical in vivo lymphoma models show that R7159/GA101 has superior efficacy to MabThera (rituximab).
About NHL
NHL is a cancer of the lymphatic system that affects one million people worldwide. There are over 20 different types of NHL and approximately 80% of all lymphomas diagnosed are NHL.
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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