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Biotech / Medical : OSI Pharmaceuticals (OSIP) - formerly Oncogene -- Ignore unavailable to you. Want to Upgrade?

To: DewDiligence_on_SI who wrote (299)	10/18/2005 9:45:28 AM
From: tuck	Read Replies (1) \| Respond to of 447

Tarceva adds no benefit to Avastin in metastatic RCC: >>SOUTH SAN FRANCISCO, Calif., Oct. 18 /PRNewswire-FirstCall/ -- Genentech, Inc. (NYSE: DNA - News) today announced that the company has performed a preliminary analysis of a randomized Phase II study designed to evaluate the incremental benefit of adding Tarceva® (erlotinib) to Avastin® (bevacizumab) in metastatic renal cell carcinoma (kidney cancer). This trial measured two co-primary efficacy endpoints, progression-free survival and response rate, and preliminary estimates suggested that the addition of Tarceva to Avastin resulted in progression-free survival and response rates similar to those achieved with Avastin alone. Due to the exploratory nature of the study, these estimates do not provide definitive conclusions with high statistical certainty with respect to differences between the treatments. Genentech will continue to analyze the study results and will submit the data for presentation at an upcoming medical meeting. "At this time we do not believe further studies of this particular combination in kidney cancer are warranted. However, we remain encouraged by the duration of progression-free survival seen in patients treated with Avastin both in this trial and in previous studies in kidney cancer," said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer. "Combining agents that target different cancer pathways remains an area of active investigation for Genentech and may be a viable alternative to chemotherapy. We will continue to vigorously investigate combinations of targeted therapies in other cancers." This exploratory Phase II, randomized, double-blind, controlled, multicenter trial enrolled 104 patients with metastatic renal cell carcinoma (RCC). Patients were randomized to receive either Avastin with Tarceva, or Avastin with placebo. Patients received Avastin every two weeks, and either Tarceva or placebo daily. All study participants had metastatic RCC of clear cell histology and had undergone prior nephrectomy (surgical removal of all or part of the kidney). Patients who had previously received systemic therapy for RCC (such as chemotherapy) were not eligible to enroll. A preliminary assessment of safety showed that adverse events in this study were similar to those observed in previous clinical trials of Avastin in combination with Tarceva, and included diarrhea, rash, nausea/vomiting, hypertension, bleeding, proteinuria and pruritus. More detailed information about adverse events will be available when the data are presented.<< snip Which is why OSIP is down and DNA is flattish this morning. Could have been worse; I gather expectations were low. Cheers, Tuck