Basel, 03 June 2010
Roche provides update on Phase III study with Avastin in aggressive non-Hodgkin's Lymphoma
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has accepted the recommendation of an independent Data and Safety Monitoring Board (DSMB) to stop enrolment into the MAIN trial, a Phase III clinical study evaluating the efficacy and safety of Avastin (bevacizumab) when added to MabThera/Rituxan (rituximab) plus CHOP (cyclophosphamide/doxorubicin/vincristine/prednisone) chemotherapy in patients with Diffuse Large B-Cell Lymphoma (DLBCL).
The DSMB’s recommendation is based on data from a recent safety and efficacy analysis of the first 720 patients enrolled into the MAIN study, which showed an unfavorable risk-benefit assessment of the addition of Avastin to the standard of care treatment MabThera/Rituxan plus CHOP. Based on currently available data, no new safety events have been identified for Avastin or MabThera/Rituxan. An assessment of whether there was a higher occurrence of known safety events of Avastin in combination with the R-CHOP regimen in the MAIN trial, where anthracyclines were given at relatively high cumulative dose, is ongoing.
These findings do not impact Avastin’s approved indications. Avastin’s broad development program, which includes more than 450 clinical trials worldwide in approximately 30 different tumor types, will continue as planned.
Roche is fully committed to developing new therapies for patients with aggressive NHL and continues intensive clinical research with new antibodies as well as molecules targeting other signaling pathways in this disease.
MAIN is a multi-center, randomized, double-blind, placebo-controlled Phase III trial comparing the efficacy of Avastin in combination with MabThera and CHOP (RA-CHOP) versus MabThera and CHOP (R-CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL).
The primary endpoint of the study is progression free survival (PFS). Secondary endpoints include safety profiles of both treatment arms, overall survival (OS), event-free survival (EFS), overall and complete response rates (ORR and CRR).
Avastin is approved in the US and Europe for the treatment of advanced stages of colorectal cancer, breast cancer, non-small cell lung cancer and kidney cancer, and Avastin is also available in the US for the treatment of patients with advanced brain cancer (glioblastoma). Avastin is the only anti-angiogenic therapy available for the treatment of these numerous advanced cancer types, which collectively cause over 2.5 million deaths each year. Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today and over 800’000 patients have been treated with Avastin so far. A comprehensive clinical programme with over 450 clinical trials is investigating the use of Avastin in various tumour types (including colorectal, breast, non-small cell lung, brain, gastric, ovarian, prostate and others) and different settings (advanced or early stage disease).
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80’000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
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