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Title: Survival Advantage Seen With Temsirolimus for Renal Cell Cancer: Presented at ASCO

"Survival Advantage Seen With Temsirolimus for Renal Cell Cancer: Presented at ASCO"

By Ed Susman ATLANTA, G.A. -- June 4, 2006 -- Patients with renal cell carcinoma with poor prognosis live longer if they receive the investigative drug temsirolimus rather than standard interferon treatment, according to interim results presented here at the American Society of Clinical Oncology 2006 Annual Meeting (ASCO). This is the first trial to validate the theory that the mammalian target of papamycin (mTOR) is a target for the treatment of cancer, said Gary Hudes, MD, director of genitourinary oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania. Dr. Hudes explained that the mammalian target of rapamycin (mTOR) controls the molecular cascade of events that leads to cell proliferation and angiogenesis. Although mTOR exists in all cells, it is overexpressed in cancer cells. The researchers theorized that by attacking this target in cancer cells the damage will be limited to the malignancy rather than to healthy cells. The phase 3 trial, presented during a press briefing on June 4[^th, randomized patients to treatment with subcutaneous interferon alone, intravenous temsirolimus, or a combination of temsirolimus and interferon.

Interferon was administered at a dose escalated from 3 million units to 18 million units 3 times a week, temsirolimus was dosed at 25 mg once a week, and the combination regimen consisted of temsirolimus 15 mg plus 6 million units of interferon 3 times weekly.

Among 626 patients enrolled at 209 sites in 26 countries, median survival was 7.3 months in the interferon patients, 10.9 months in the temsirolimus arm, and 8.4 months in the combination arm.

The difference between temsirolimus and interferon monotherapy reached statistical significance at the P =.0069 level. The 2.6-month survival gain represents a 49% increase.

"Temsirolimus 25 mg intravenously administered weekly can be considered standard therapy for patients with metastatic renal cell cancer and poor-risk factors," Dr. Hudes said.

The trial was sponsored by Wyeth Research.

[Presentation title: A Phase 3, Randomized, 3-Arm Study of Temsirolimus (TEMSR) or Interferon-Alpha (IFN) or the Combination of TEMSR + IFN in the Treatment of First-Line, Poor-Risk Patients With Advanced Renal Cell. Abstract LBA4]

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