Pharmaprojects R&D Pipeline News Feed
Phase III trial of sorafenib in lung cancer halted early
22 Feb 2008
Bayer and its partner Onyx Pharmaceuticals have stopped a Phase III trial of sorafenib tosylate (Nexavar) earlier than planned following an interim analysis of data. The ESCAPE trial, in more than 900 patients worldwide, had to be terminated after the independent data monitoring committee concluded that the trial would not meet its endpoint of improved overall survival.
Although the safety of sorafenib was as expected, higher mortality was observed in the subset of patients with squamous cell carcinoma of the lung treated with sorafenib added to carboplatin and paclitaxel versus those treated with carboplatin and paclitaxel alone. Bayer said that it was too early to know if the lack of an overall survival benefit in the trial could be ascribed to the negative results in this subset of patients.
Henry Fuchs, Onyx' Chief Medical Officer, stated that the data did not support further pursuit of development of sorafenib in non-squamous nsclc in combination with carboplatin and paclitaxel. Sorafenib is in a second Phase III trial in nsclc, NExUS, and further Phase II trials are in progress. Bayer and Onyx are yet to comment on the future of these trials.
