Nexavar (aka, Sorafenib) Phase 3 Data Released at ECCO (ONXX, BAY, PFE)

Includes: BAYRY, ONXX, PFE
by: BioBlogger

Last week at the European Conference of Cancer (OTC:ECCO), Onyx (ticker: ONXX) and Bayer (ticker: BAY) released interim survival data from the Nexavar Phase 3 trial in second-line renal cell carcinoma (RCC). Results showed that Nexavar improved survival 39% versus placebo, but the result failed to reach statistical significance. Nevertheless, the trend in median survival was indicative of a strong clinical response.

The interim survival analysis was conducted upon the predefined event of 220 deaths of which 97 were in the Nexavar arm and 123 were in the placebo arm. Due to the design of the trial, statistical significance was defined as a p-value of less than 0.0005 rather than the usual 0.05. Because of the crossover design of the study, which allows placebo patients to crossover to the Nexavar arm, it is unlikely that the final survival analysis will show significance at the final analysis.

The study did show impressive survival trends. At the time of analysis, placebo patients reached a median survival at 14.7 months whereas the Nexavar arm had not reached median survival. The current data suggest Nexavar could achieve a median survival of over 19 months, which is favorable to the 16.4 month median survival exhibited by Pfizer’s (ticker: PFE) Sutent in its Phase 2 study.

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