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Nexavar Shows Promising Results in Phase III Trial for Advanced Renal Cell Carcinoma

Strategic Insights

— 2 min read

Dr. Bernard Escudier, Head of Immunotherapy and Innovative Therapy Unit at the Gustave-Roussy Institute in Paris, presented interim results from the Phase III trial of Nexavar in patients with advanced renal cell carcinoma (RCC) at the 13th European Cancer Conference (ECCO). The study showed a significant improvement in survival for patients receiving Nexavar, with a 39% estimated improvement in survival compared to those receiving placebo (p=0.018, hazard ratio 0.72). This finding builds on previous results demonstrating that Nexavar significantly delayed disease progression in advanced kidney cancer patients.

Key Takeaways:

  • The interim analysis of the Phase III trial showed an estimated 39% improvement in survival for patients receiving Nexavar compared to those receiving placebo (p=0.018, hazard ratio 0.72).
  • The study found that 74% of Nexavar patients had tumor shrinkage, compared to 20% of placebo patients.
  • Nexavar was granted priority review status by the FDA, which means the agency will review the application within six months of receipt.
  • The marketing authorization application (MAA) was submitted to the European Medicines Agency (EMEA) to market Nexavar in Europe.
  • The Phase III trial had more than 900 patients with advanced kidney cancer participating, with endpoints including overall survival, progression-free survival, best response, quality of life, and safety.
  • Patients were randomized one-to-one to receive either 400 mg Nexavar or placebo twice a day.
  • The study was modified to allow patients who were receiving placebo to "cross over" to drug treatment based on the magnitude of the progression-free survival benefit for Nexavar-treated patients.
  • The Phase III trial demonstrated significant improvement in progression-free survival, with Nexavar significantly prolonging progression-free survival (p > 0.000001).
  • The rate of significant adverse events was comparable for patients receiving Nexavar or placebo.
  • Grade 3 adverse events were modestly elevated in the Nexavar-treated group (31 percent) as compared to placebo patients (22 percent).

Statistics:

  • 39% estimated improvement in survival for patients receiving Nexavar compared to those receiving placebo (p=0.018, hazard ratio 0.72)
  • 74% of Nexavar patients had tumor shrinkage, compared to 20% of placebo patients
  • The Phase III trial had more than 900 patients with advanced kidney cancer participating
  • Patients were randomized one-to-one to receive either 400 mg Nexavar or placebo twice a day
  • The study was modified to allow patients who were receiving placebo to "cross over" to drug treatment based on the magnitude of the progression-free survival benefit for Nexavar-treated patients
  • 31% of Nexavar patients experienced grade 3 adverse events, compared to 22% of placebo patients
  • The rate of significant adverse events was comparable for patients receiving Nexavar or placebo

Sources:

  • Bayer Pharmaceuticals Corporation press release, June 2005
  • Onyx Pharmaceuticals, Inc. press release, June 2005
  • European Cancer Conference (ECCO) press release, June 2005
  • U.S. Food and Drug Administration (FDA) press release, July 2005
  • European Medicines Agency (EMEA) press release, September 2005
  • The Cleveland Clinic Taussig Cancer Center press release, April 2005
  • Gustave-Roussy Institute press release, April 2005
  • Bayer HealthCare AG Annual Report, 2004

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