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Renal Cancer Patients Show Response to Experimental BAY 43-9006: Presented at AACR-NCI-EORTC

By Ed Susman

BOSTON, MA -- November 21, 2003 -- About 42% of patients with progressive renal cell cancer achieved tumour shrinkage while taking the oral signal transduction inhibitor BAY 43-9006.

In a phase 2 study, 21 of 50 evaluable renal cancer patients experienced a reduction in their tumour burden by at least 25% within 12 weeks of treatment with the experimental oral drug, which targets the Raf kinase, an enzyme that regulates tumour cell proliferation and may also play a role in the growth of new blood vessels to feed the tumour, said Mark Ratain, MD, professor of medicine at the University of Chicago, Illinois, United States.

"The frequency of tumour shrinkage and disease stabilisation is quite encouraging," Dr. Ratain said in a presentation here November 20^th at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. "All patients in this study had progressive disease that did not respond to at least one prior systemic treatment. The benefits observed in this trial suggest that BAY 43-9006 has exciting potential for this patient population."

William Sellers, MD, assistant professor of medicine, Harvard Medical School, Boston, Massachusetts, United States, said BAY 43-9006 is an example of where science is heading in the treatment of cancer -- interrupting the molecular signaling that allows cancers to grow and metastasise. Dr. Sellers moderated a press briefing at which Dr. Ratain discussed his findings. "BAY 43-9006 targets kinase," Dr. Sellers explained. "Kinases are enzymes that transport phosphates that are important signaling molecules."

Dr. Ratain said few renal cell cancer patients respond to therapy; so, the initial success with the drug has been encouraging. He said one patient achieved a response that was durable for 42 weeks before his disease progressed. "It is quite remarkable to see tumour shrinkage in these patients," he said, "some of whom have gone through six or seven different therapies without showing improvement."

In the study, patients were treated with the new compound in an open-label fashion. Those who showed a tumour reduction of >25% after 12 weeks of therapy remained on BAY 43-9006. Patients who progressed on treatment or were unable to tolerate side affects associated with treatment -- notably a rash or gastrointestinal distress -- were dropped from the study. Patients with stable disease during the first period were randomised to receive either the experimental drug or a matching placebo. The patients received doses of BAY 43-9006 400 mg b.i.d.

Among the 50 renal cancer patients who completed 12 weeks of therapy, 13 had stabilised disease and were continued in the randomised portion of the study through 18 weeks; 12 of those patients have completed 24 weeks of therapy, Dr. Ratain said.

The study is supported by Bayer of West Haven, Connecticut, United States.


[Study title: A Phase II Study of BAY 43-9006 Using the Randomized Discontinuation Design in Patients With Advanced Refractory Cancer. Abstract C254]

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