Healthcare Industry News: NSABP C-08
News Release - October 20, 2008
Genentech Announces Phase III Study of Avastin Plus Chemotherapy in Adjuvant Colon Cancer Will ContinueSOUTH SAN FRANCISCO, Calif.--(HSMN NewsFeed)--Genentech, Inc. (NYSE:DNA ) today announced that it has been informed by the National Surgical Adjuvant Breast and Bowel Project (NSABP) that an ongoing Phase III study (NSABP C-08) of Avastin® (bevacizumab) plus chemotherapy in patients with early-stage colon cancer will continue as planned. The NSABP’s decision to continue the trial was based on a recommendation from an independent Data Monitoring Committee (DMC) after a planned interim analysis.
The study of 2,710 patients is being conducted by the NSABP and is sponsored by the National Cancer Institute. The independent DMC is responsible for monitoring patient safety and efficacy, as well as recommending whether to stop or continue the trial. Genentech anticipates final results from NSABP C-08 in mid-2009.
About the Study
NSABP C-08 is a randomized, multi-center Phase III study designed to evaluate the effect of FOLFOX (5-fluorouracil, leucovorin and oxaliplatin) chemotherapy with or without Avastin on disease-free survival in patients with resected Stage II or III adenocarcinoma of the colon. The trial is being conducted primarily in the United States. Patients enrolled in the two-arm study were randomized after surgery to receive either FOLFOX alone for six months or Avastin in combination with FOLFOX for six months followed by an additional six months of Avastin monotherapy. Overall survival is a secondary endpoint of the study.
At the American Society of Clinical Oncology 2008 annual meeting, Allegra et al. presented interim safety data from NSABP C-08 that showed no new or unexpected safety events in the Avastin arm. The incidence of non-cancer-related deaths was similar between the treatment arms and no significant increases in gastrointestinal (GI) perforation, hemorrhage, arterial or venous thrombotic events or deaths were observed in the Avastin arm. The analysis showed events that occurred more often in the Avastin plus chemotherapy arm included Grade 3 or greater hypertension (12.7 percent vs. 1.8 percent), wound healing complications (1.7 percent vs. 0.3 percent), pain (6.9 percent vs. 3.4 percent), proteinuria (0.9 percent vs. 0.2 percent), and Grade 2 or greater sensory neuropathy (49.4 percent vs. 43.2 percent).
Avastin is a biologic antibody designed to specifically inhibit the vascular endothelial growth factor (VEGF) protein that plays an important role in the development and maintenance of blood vessels, a process known as angiogenesis. VEGF is a potent activator of angiogenesis from the earliest to latest stages of cancer growth. By inhibiting VEGF, Avastin may have distinct effects on early- and late-stage tumors. In early-stage cancer, VEGF is believed to play an important role in allowing cancer cells to establish as tumors. For late-stage tumors, Avastin may interfere with the existing blood supply to a tumor, which is thought to be critical to a tumor's ability to grow and spread in the body (metastasize).
Avastin is approved by the Food and Drug Administration (FDA) in combination with intravenous (IV) 5-fluorouracil (FU)-based chemotherapy for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum, and for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel. For more information on angiogenesis, visit http://www.gene.com. For full Prescribing Information and Boxed Warnings on Avastin, visit http://www.avastin.com.
The most serious side effects associated with Avastin across all trials were gastrointestinal perforation, slow wound healing, severe bleeding, formation of an abnormal passage from parts of the body to another part, blood clots, severe high blood pressure, nervous system and vision disturbances, reduced white blood cell counts, kidney malfunction, and congestive heart failure.
The most common serious adverse events that may have occurred for Avastin for first- and second-line metastatic colorectal cancer and first-line NSCLC included reduced white blood cell counts, tiredness, high blood pressure, infection, severe bleeding, weakness, abdominal pain, pain, blood clots, a brief loss of consciousness, diarrhea, constipation, nausea, vomiting, dehydration, blockage of the bowel, numbness and tingling in fingers and toes, nervous system disturbances, and headache.
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines for patients with significant unmet medical needs. The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.
This press release contains a forward-looking statement regarding the timing of clinical trial results. Such statement is a prediction and involves risks and uncertainties such that actual results may differ materially. Actual results may be affected by a number of factors including, but not limited to, unexpected safety or efficacy issues, or the need for additional data, data analysis or clinical studies. Please also refer to the risk factors described in Genentech's periodic reports filed with the Securities and Exchange Commission. Genentech disclaims, and does not undertake, any obligation to update or revise any forward-looking statement in this press release.
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