Bayer reports early stop for Nexavar trial

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have given an update on the phase III trial of Nexavar (sorafenib) in patients with non-small cell lung cancer (NSCLC).

The companies report that, following a planned interim analysis, the trial was stopped early, as the independent data monitoring committee concluded that the study would not meet its primary endpoint, one of improved overall survival in patients.

In the Escape trial, Nexavar was administered to patients in combination with carboplatin and paclitaxel in patients with NSCLC.

While safety events were consistent with previous reports, a higher mortality rate was seen in squamous cell carcinoma patients treated with sorafenib, carboplatin and paclitaxel when compared to those treated with the chemotherapeutic agents alone.

Susan Kelley, vice-president of oncology at Bayer HealthCare Pharmaceuticals, said: “While we are disappointed in this outcome, Bayer and Onyx remain committed to our comprehensive pan-tumour clinical trial program for Nexavar.”

She added that the compound has proven clinical benefits for patients with advanced kidney cancer and liver cancer and the companies will continue to assess its potential against other cancers.

Earlier this month, Nexavar received marketing authorisation in Japan for the treatment of advanced renal cell carcinoma, a move described as a “crucial step” for patients with the condition.