Cary Posted July 7, 2004 Share Posted July 7, 2004 http://tinyurl.com/yrjxg July 9, 2004 p39 Avastin, Tarceva combination yields initial promising results for cancers. 2004 JUL 9 -- Genentech, Inc., (DNA) and OSI Pharmaceuticals (OSIP) announced results from phase I/II clinical studies examining the combination of Avastin (bevacizumab) and the investigational small molecule Tarceva (erlotinib HCl) in the treatment of metastatic renal cell carcinoma (kidney cancer) and relapsed non-small cell lung cancer (NSCLC). These trials are important because patients received no chemotherapy and instead were treated with a combination of two therapies targeted at two distinct avenues of growth in cancer: angiogenesis and EGFR signaling. The results were presented at the 40th Annual Meeting of the American Society of Clinical Oncology (ASCO). Avastin is a therapeutic antibody designed to inhibit angiogenesis, the process by which new blood vessels develop, which is necessary to support tumor growth and metastasis. Avastin is currently approved in the United States for use in combination with intravenous 5-Fluorouracil (5-FU)-based chemotherapy as a treatment for first-line metastatic colorectal cancer. Tarceva, an investigational therapy, is an oral, once-a-day, small molecule designed to target the human epidermal growth factor receptor 1 (HER1/EGFR) pathway, which is one of the factors critical to cell growth in many cancers. "As cancer patients lives longer, quality of life and avoiding toxic side effects become more important," said Gwen Fyfe, MD, Genentech's vice president, Clinical Hematology/Oncology. "Evaluating the combination of Avastin and Tarceva in certain cancers is representative of our strategy to inhibit tumor growth by simultaneously targeting different cancer pathways. We are encouraged by the response and progression-free survival data observed in these studies of patients with advanced kidney and lung cancers and believe these data support future evaluation of this combination in multiple tumor types," Fyfe said. In addition to the combination studies in recurrent NSCLC and metastatic kidney cancer, preliminary data from studies evaluating the combination of Avastin plus Tarceva in metastatic breast cancer and recurrent and/or metastatic head and neck cancer will be presented at this year's ASCO meeting. This single-arm phase II study, presented by John Hainsworth, MD, of the Sarah Cannon Cancer Center in Nashville, Tennessee, focused on preliminary results from 62 patients with metastatic renal cell carcinoma (kidney cancer) treated with a combination of Avastin and the investigational drug Tarceva. At the time of analysis, 62 patients had been enrolled in the study and 58 were evaluable for response. The authors reported that at 8 weeks, 21% of patients (12/58) experienced an objective response (defined as a 50% or greater decrease in the size of a tumor) to the combined therapy and 66% (38/58) experienced a minor response or disease stabilization. At 6 months, 67% of the evaluable patients (39/58) had progression-free survival and after 1 year, 50% of patients (29/58) had progression-free survival. Overall survival after 6 months was 92% and after 1 year was 81%. The Grade 3 or 4 adverse events observed in the study included hypertension (8%, 5/58), diarrhea (10%, 6/58), rash (13%, 8/58), nausea/vomiting (10%, 6/58), bleeding (5%, 3/58), pruritus (3%, 2/58), proteinuria (3%, 2/58), neuropathy (3%, 2/58) and edema (2%, 1/58). Alan Sandler, MD, of Vanderbilt-Ingram Cancer Center, reported on results from a multicenter phase I/II study designed to evaluate the combination of Avastin and Tarceva in the treatment of recurrent non- small cell lung cancer (NSCLC) patients. To date, 40 patients have been enrolled in the trial. At the time of analysis, median survival was 12.6 months, median progression-free survival was 7 months and the estimated 1-year survival was 54%. Partial responses were observed in 20% of patients (8/40) and an additional 65% of patients (26/40) achieved stable disease in the study. The most frequent adverse events reported were mild-to- moderate rash (93%, 37/40), diarrhea (78%, 31/40) and proteinuria (18%, 7/40). Traditionally patients with relapsed NSCLC are treated with chemotherapy, which may be very poorly tolerated by some advanced patients. If randomized, phase III trials of Avastin plus Tarceva show clinical benefit, this combination could provide an important treatment option that does not include chemotherapy. Quote Link to comment Share on other sites More sharing options...
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