Wyeth will continue development of its oncologic temsirolimus for renal cell carcinoma and mantle cell lymphoma despite the termination of a Phase III trial in breast cancer.

The company is ending the clinical trial of the oral formulation of temsirolimus, in combination with Novartis' Femara (letrozole), for the treatment of advanced metastatic breast cancer due to a failure to demonstrate increased efficacy over letrozole alone, the company said March 16.

An independent data monitoring committee recommended the action following an interim analysis of clinical data trial data of approximately 1,100 subjects, Wyeth said.

The company has two additional temsirolimus Phase III trials ongoing with the intravenous formulation of the agent for the treatment of renal cell carcinoma and mantle cell lymphoma. A separate IDMC found that the agent exhibited activity in renal cancer, based on Phase I and II data.

The company intends to file an NDA for the renal cell indication in the fourth quarter of 2006, with a submission for mantle cell cancer towards the end of 2007.

Despite the setback with the breast cancer trial, the firm said it remains committed to studying temsirolimus in other cancer indications.

-Christopher Hollis

Wyeth Ends Temsirolimus Breast Cancer Trial

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