Bayer: Kidney Cancer Drug Offers Hope for Patients and Pipeline
Posted on: Tuesday, 26 October 2004, 03:00 CDT
Bayer [BAY.F] and Onyx Pharmaceuticals [ONXX] anticipate using the encouraging Phase II trial data in support of forthcoming Phase III trial results to seek registration for the drug, with a US launch expected in 2006.
The Phase II trial administered 400mg of BAY 43-9006 twice daily to 502 patients, 202 of which had advanced progressive kidney cancer. Following a 12-week induction phase, 65 out of the 202 patients with stable disease were randomized to receive a further 12-week course of BAY 43-9006 or a placebo.
Of the 202 kidney cancer patients, 70% showed either tumor shrinkage or disease stabilization, while eight patients exhibited a partial response. Time to tumor progression for the entire kidney cancer population was 169 days, which is a significant improvement when compared to the typical 60-90 days reported for control groups in other studies. Adverse events included skin reactions, rash, diarrhea, fatigue, weight loss and hypertension, all of which were manageable and reversible.
BAY 43-9006 is an oral cytostatic that targets the RAF/MEK/ERK signaling pathway to inhibit cell proliferation and the VEGFR-2/PDGFR-beta signaling cascade to inhibit angiogenesis.
Due to the poor prognosis for kidney cancer patients, the market has typically suffered from a low level of R&D investment. The FDA's decision in April 2004 to grant BAY 43-9006 orphan drug status for the treatment of advanced kidney cancer was a notable exception to this trend, and this award should facilitate the drug's onward development.
BAY 43-9006 holds great promise for Bayer's pharmaceuticals unit, which is currently suffering from a weak pipeline following the recall of cholesterol drug Baycol and stiff competition for its antibiotic Cipro. If the ongoing Phase III trial in over 800 advanced kidney cancer patients meets its primary endpoint of overall survival, it could help establish Bayer as a significant player within the oncology market.
Source: Datamonitor
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