Genentech drops Avastin/Tarceva study in kidney cancer

By E. Janene Geiss

Philadelphia, Oct. 18 - Genentech, Inc. announced Tuesday that preliminary analysis of a randomized phase II study designed to evaluate the incremental benefit of adding Tarceva to Avastin showed the combination was not better in treating kidney cancer than Avastin alone.

Genentech said it would not pursue further studies of this combination in kidney cancer, company officials said in a news release.

"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," Hal Barron, Genentech senior vice president of development and chief medical officer, said in the release.

Company officials did say they 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.

The exploratory phase II, randomized, double-blind study enrolled 104 patients with metastatic renal cell carcinoma. Patients were randomized to receive either Avastin with Tarceva or Avastin with placebo. Preliminary safety results showed that adverse events in this study were similar to those observed in previous clinical trials of Avastin in combination with Tarceva, officials said.

Avastin, which is marketed in the United States by Genentech and Roche Group outside of the United States, is a therapeutic antibody designed to inhibit growth of a protein that plays a role in tumor angiogenesis and maintenance of existing tumor vessels.

Tarceva, marketed by Genentech and OSI Pharmaceuticals in the United States and by Roche Group outside of the United States, is a small molecule designed to target a human epidermal growth factor critical to cell growth in some lung cancers and other tumors.

In response to Genentech's news, Merrill Lynch analyst Eric Ende said the discontinuation of Tarceva could reduce the drugs peak sales by $100 million to $450 million. Ende, while maintaining buy ratings with both Genentech and OSI, lowered OSI's price target to $34 from $51 based on the Tarceva discontinuation.

Genentech is a South San Francisco, Calif.-based biotechnology company that develops, manufactures and commercializes biotherapeutics.

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