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ESCAPE trial in NSCLC ends after higher mortality rates found
Sorafenib and chemotherapy combination not likely to meet primary endpoint of overall survival.
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A phase-3 trial of sorafenib in the treatment of patients with non-small cell lung cancer was halted by an independent Data Monitoring Committee, which found that the study will not meet its primary endpoint of overall survival.
Bayer Healthcare Pharmaceuticals and Onyx Pharmaceuticals Inc. announced the trial’s discontinuation on Monday.
The phase-3 trial—Evaluation of Sorafenib, Carboplatin and Paclitaxel Efficacy in NSCLC (ESCAPE)—was a multi-center, randomized, double-blind, placebo-controlled study to assess sorafenib (Nexavar, Bayer) in combination with chemotherapy agents carboplatin and paclitaxel in more than 900 patients with NSCLC.
Researchers randomly assigned patients to receive 400 mg of oral sorafenib or placebo twice daily, along with carboplatin and paclitaxel for up to six cycles. Compared with patients treated with chemotherapy alone, those treated with sorafenib and carboplatin and paclitaxel had higher mortality. Additional data from the trial is scheduled for presentation at an upcoming scientific meeting.
Currently, sorafenib is approved for liver cancer in more than 30 countries and for advanced kidney cancer in more than 60 countries, according to a press release. The drug is also being evaluated as a single agent or combination therapy in metastatic melanoma, breast cancer and as adjuvant therapy for kidney and liver cancers. – by Stacey L. Adams