The phase III trial evaluated Nexavar when administered in combination with a standard dosing schedule of the chemotherapy drugs, carboplatin and paclitaxel. The study was designed to measure the safety and efficacy of Nexavar when co-administered with chemotherapy, and had progression-free survival as its primary endpoint, defined as the time that a patient lives without meaningful tumor growth. The safety profile of these agents in combination was comparable to those previously reported for these agents in combination.
“This trial does not change our commitment to, and belief in, Nexavar. We hope to demonstrate utility in a wide variety of tumors and we will continue to broaden our clinical program, including increasing our attention to the more common malignancies in which anti-angiogenics have demonstrated activity,” said Hollings Renton, Onyx's president and CEO.
Nexavar is currently approved in a number of countries, including the US and the European Union, for the treatment of patients with advanced kidney cancer.