Basel, Switzerland – 8 December 2008. 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 CD20 antibody in development, could offer powerful benefits in treating patients with relapsed or refractory types of CD20 positive non-Hodgkin’s lymphoma (NHL), recognised as a difficult to treat patient population.Basel, Switzerland – 8 December 2008. 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 CD20 antibody in development, could offer powerful benefits in treating patients with relapsed or refractory types of CD20 positive non-Hodgkin’s lymphoma (NHL), recognised as a difficult to treat patient population.
Results from the phase I, dose escalation portion of this phase I/IIa study demonstrate that of the 21 heavily pre-treated B-cell NHL patients that were enrolled (3 median prior therapies), nine showed an objective response to treatment with R7159/GA101 monotherapy. Of these, four patients were regarded as being in complete remission following treatment, and five experienced a partial response. A further five showed stabilization of their disease. Of the 11 patients whose treatment had included prior hematopoietic stem cell transplant (transplant of stem cells from the bone marrow to produce new blood cells), six were responders. As well as demonstrating strong efficacy data, 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 data presented at ASH will be supplemented by further dosing studies and further clinical data is expected in 2009.
“Although GA101 is still in the early stages of development, we are excited by these early data,” said Manfred Heinzer, Head Strategic Marketing Oncology, Roche. “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 in patients with CD20+ malignant disease. 21 NHL patients, 20 of whom previously received MabThera (rituximab) have been involved the phase I dose escalation portion of the study. The endpoints in the phase I portion included safety and tolerability, dose-limiting toxicity, pharmacokinetics, preliminary efficacy. 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 glycoengineered monoclonal anti-CD20 antibody to enter clinical trials. It is a novel type II anti-CD20 antibody with increased direct cell death vs rituximab and enhanced ADCC. R7159/GA101 has shown a similar safety profile to MabThera (rituximab) and promising efficacy in patients with CD20-positive malignant disease. Preclinical in vivo lymphoma models show that R7159/GA101 has superior efficacy to MabThera.
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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