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Temsirolimus Equivalent to Currently Used Chemotherapy in Metastatic or Locally Recurrent Endometrial Cancer: Presented at AACR-NCI-EORTC

By Maggie Schwarz

PHILADELPHIA, PA -- November 21, 2005 -- A high level of activity was seen at an early stage of clinical research with temsirolimus in women with metastatic and/or locally recurrent endometrial cancer.

This promising result was reported by Amit Oza, MD, Associate Professor of Medicine, Princess Margaret Hospital, University of Toronto, Toronto, Ontario, Canada.

Dr. Oza and coinvestigators presented results of this phase 2 study of temsirolimus -- a derivative of rapamycin that inhibits mammalian target of rapamycin (mTOR) -- here on November 17^th at the International Conference Molecular Targets and Cancer Therapeutics.

The conference was organized jointly by the American Association for Cancer Research - National Cancer Institute - European Organisation for Research and Treatment of Cancer (AACR-NCI-EORTC).

Phosphatase and tensin homolog (PTEN) is a tumor suppressor gene whose mutation leads to loss of protein expression and function. The mutation appears to play a significant role in the development of endometrial cancer, with losses of protein expression and function being reported in 26% to 80% of endometrial cancers.

Early research that demonstrated frequent loss of PTEN and anti-tumor activity induced with mTOR inhibition led Dr. Oza and colleagues to examine temsirolimus in women with endometrial cancer.

The research team evaluated a cohort of women with recurrent or metastatic endometrial cancer who had not received chemotherapy but had been treated with up to one prior line of hormonal therapy. The 18 women received temsirolimus at a dose of 25 mg weekly for a median of 24 weeks.

Results show that 31% of 16 evaluable women had a confirmed partial response; 63% had stable disease as best response; and 6% had progressive disease.

"It's very encouraging to see such a high level of activity at this early stage," Dr. Oza said. "The results are equivalent to those of currently used cytotoxic chemotherapy. It's really a stunning result."

The investigators plan to continue and complete this study, to examine temsirolimus in women who have had chemotherapy and in combination with chemotherapy. Then they will proceed to an international trial.


[Presentation title: A Phase II Study of Temsirolimus (CCI-779) in Patients with Metastatic and/or Locally Recurrent Endometrial Cancer -- NCIC CTG IND 160. Abstract B269]

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