Onyx Pharmaceuticals (ONXX) Provides Update for Phase II Studies Evaluating Nexava in Patients with Advanced Melanoma and Renal Cell Carcinoma
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In Today's 8-K Filing: On December 18, 2006, Onyx Pharmaceuticals (Nasdaq: ONXX) provided the following update on two Phase II studies evaluating Nexavar (sorafenib) tablets in patients with advanced melanoma and in patients with advanced renal cell carcinoma (RCC). Phase II studies tend to be smaller studies designed to gather additional information either for publication or to inform the design of subsequent trials. The full data from these studies are expected to be submitted for presentation at scientific congresses in the first half of 2007.
The Phase II study in chemo-naive melanoma patients compared Nexavar in combination with dacarbazine (DTIC) versus placebo in combination with DTIC. There was a trend toward improved progression-free survival (PFS) in patients in the Nexavar arm versus patients in the placebo arm. Based on 80 progression events, median PFS was 21.1 weeks and 11.7 weeks respectively for Nexavar in combination with DTIC as compared to DTIC plus placebo.
The multi-center Phase II, randomized, controlled trial was designed to assess the efficacy and tolerability of Nexavar in combination with dacarbazine (DTIC) in first-line therapy of patients with advanced melanoma. One hundred and one patients were randomized to receive DTIC plus continuous oral Nexavar or DTIC plus placebo. The primary outcome measured was progression-free survival, defined as the time that a patient lives without evident tumor growth. Overall survival data are maturing.
In a Phase II study evaluating Nexavar in treatment-naïve RCC patients, progression-free survival was comparable for patients who received either Nexavar or Interferon (IFN). Based on 121 progression events, median PFS was 5.6 months and 5.7 months, respectively, for IFN- and Nexavar-treated patients. Safety for each agent was consistent with what has been reported previously.
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