Genentech, Inc. 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.
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).