Phase III Trial of Nexavar® in Chemotherapy-Naive Patients with Advanced Melanoma Does Not Meet Primary Endpoint

Study stopped based on interim analysis
Leverkusen. – Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. today announced that a Phase III trial evaluating Nexavar® (sorafenib) tablets in patients with unresectable stage III or stage IV melanoma was stopped early following a planned interim analysis by an independent Data Monitoring Committee (DMC). The trial was sponsored by the National Cancer Institute and led by the Eastern Cooperative Oncology Group (ECOG) under a Clinical Trials Agreement between NCI and Bayer and Onyx. The DMC concluded that the study would not meet the primary endpoint of improved overall survival among patients receiving Nexavar in combination with the chemotherapeutic agents carboplatin and paclitaxel versus patients receiving placebo plus the chemotherapeutic agents. The treatment effect was comparable in each arm. The DMC also reported there were no unexpected serious side effects, though the final analysis of data will occur per protocol and statistical analysis plan.

Bayer and Onyx will further review the findings of this analysis and DMC recommendation to determine what, if any, impact these data might have on other ongoing Nexavar melanoma trials. Data from this study is expected to be presented at an upcoming scientific meeting.

“We’re disappointed with the results of the study and that the therapy did not bring benefit to patients with melanoma, a historically difficult tumor to treat,” said Dimitris Voliotis, Vice President in Global Clinical Oncology at Bayer HealthCare. “Onyx and Bayer remain committed to our broad clinical program to investigate the potential of Nexavar in a wide range of cancers, and we intend to build upon the success of Nexavar in our approved indications in hepatocellular carcinoma (liver cancer) and advanced renal cell carcinoma (kidney cancer).”

About the Phase III trial
The multicenter, randomized, double-blind, placebo-controlled Phase III study enrolled patients with unresectable stage III or stage IV melanoma at more than 200 clinical sites in the United States and Australia. The primary endpoint was overall survival, and secondary endpoints included progression-free survival and response rate.

Patients were randomized to receive 400mg oral Nexavar twice daily or placebo, in addition to two chemotherapeutic agents – carboplatin and paclitaxel. Following ten cycles of Nexavar plus chemotherapy, patients who achieved a response to the combination continued in a maintenance phase where Nexavar or placebo was administered as a single agent until disease progression.