Wyeth ends phase 3 metastatic breast cancer program with oral temsirolimus

By Elaine Rigoli

Tampa, Fla., March 16 - Wyeth Pharmaceuticals, a division of Wyeth, announced Thursday its decision to discontinue the Horizon phase 3 clinical trial program of Wyeth's investigational drug temsirolimus oral tablets in combination with letrozole (Femara), a currently approved breast-cancer therapy, for first-line use in postmenopausal women with hormone-receptor positive metastatic breast cancer.

This decision was based upon the recommendation of an Independent Data Monitoring Committee after review of data from a planned interim analysis, according to a news release.

The Horizon study compared the combination of temsirolimus oral tablets and letrozole versus letrozole alone. The committee advised that continuation of the trial was unlikely to achieve the targeted level of efficacy for the combination therapy compared to letrozole alone, the release said.

The committee concluded that the risk/benefit ratio for treatment of metastatic breast cancer did not favor continuation and recommended that the trial be discontinued, the release said.

"While not the anticipated outcome, it is unfortunately not unusual for cancer drugs to work in some tumor types and not others, or even work in only some specific subpopulations of cancer patients," says Gary L. Stiles, executive vice president and chief medical officer, in a statement.

"We remain committed to studying temsirolimus in other cancer indications," he added.

While the phase 3 trial for women with hormone-receptor positive metastatic breast cancer involved an oral formulation of temsirolimus, two other phase 3 clinical trials studying temsirolimus in renal cell carcinoma and mantle cell lymphoma using an intravenous formulation are continuing, the release said.

Wyeth Pharmaceuticals, a division of Wyeth, is a research-driven pharmaceutical and health care products company based in Madison, N.J.

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