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May 31, 2003

Early Study Results Promising: Oral Medication Active Against Skin Cancer

Abramson Cancer Center Research Presented at ASCO: Abstract #2854

(Chicago, IL) - Researchers from the Abramson Cancer Center of the University of Pennsylvania today presented early study results showing that a new kind of drug, a Raf kinase inhibitor, is well tolerated and may prove effective in treating patients with metastatic melanoma, the most severe form of skin cancer. Standard chemotherapy has limited effectiveness against metastatic melanoma (i.e. dacarbazine).

The findings were released by co-Principal Investigators Keith Flaherty, MD, and Peter O'Dwyer, MD, at the 39th Annual Meeting of the American Society for Clinical Oncology, taking place in Chicago, May 31 to June 3. Early results from a Phase I clinical study show that the Raf kinase inhibitor produced promising anti-cancer activity in patients with metastatic (or widespread) melanoma: Seven out of ten patients tested showed benefit that lasted up to ten months. The investigational drug, named BAY43-9006, is a pill therapy under development by Bayer and Onyx Pharmaceuticals.

"It is promising to see patients do so well, this early in the research," said Flaherty, Instructor of Medicine at the Abramson Cancer Center of the University of Pennsylvania. "Melanoma is a disease that does not frequently respond to current therapies."

Raf kinase inhibitors are small molecules that prevent or interrupt the action of Raf kinase, a key enzyme in the chain reaction of the body's chemistry that triggers cell growth. Abnormal activation of this pathway is a common thread in the development of most cancers, including two-thirds of melanomas. By blocking the action of Raf kinase, scientists hope they can reverse the progression of these tumors.

Twenty patients were enrolled in the first part of the Phase I study, which began in April 2002. The Phase I trial was funded through a research grant from Bayer Pharmaceuticals.

The primary goal of the Phase I trial is to determine a safe dosage of the Raf kinase inhibitor for use in future studies. Patients were given the Raf kinase inhibitor, twice daily - in varying doses of either 100 mg, 200 mg, or 400 mg - for a period of three weeks, in combination with two standard cancer therapies, carboplatin and paclitaxel.

The safety profile of the combination therapy was determined as favorable, with minimal and reversible side effects, such as rash and diarrhea.

"With this study, we have confirmed that the Raf kinase inhibitor can be used safely in conjunction with other standard cancer therapies," said O'Dwyer, Director of the Developmental Therapeutics Program and Professor of Medicine at the Abramson Cancer Center of the University of Pennsylvania. "Associated laboratory studies show that the Raf kinase inhibitor, at these doses, blocks the target pathway. Our next step is to continue to investigate this further in order to develop effective therapies for this life-threatening disease."

For 2003, the American Cancer Society estimates that over 54,000 Americans (2,700 Pennsylvanians) will be diagnosed with melanoma and 7,600 will die from the disease.

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Editor's Note: Neither Drs.Flaherty or O'Dwyer have any financial interest in Bayer or Onyx Pharmaceuticals.





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