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news.Bayer HealthCare Pharmaceuticals, the US-based pharmaceuticals unit of Bayer HealthCare, and Onyx Pharmaceuticals, a biopharmaceutical company, have reported that a Phase III trial evaluating Nexavar tablets in patients with unresectable stage III or stage IV melanoma was stopped early following a planned interim analysis by the independent data monitoring committee.
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The trial was sponsored by the National Cancer Institute (NCI) and led by the Eastern Cooperative Oncology Group under a clinical trials agreement between NCI and Bayer and Onyx.
The data monitoring committee (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 that there were no unexpected serious side effects, though the final analysis of the data will occur per protocol and statistical analysis plan.
Bayer and Onyx will further review the findings of this analysis to determine what, if any, impact these data might have on other ongoing Nexavar melanoma trials.
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 US and Australia. The primary efficacy 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 10 cycles of Nexavar or placebo 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.
Todd Yancey, vice president of clinical development at Onyx, said: “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. 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 and advanced renal cell carcinoma.”