Bayer: Enrolment completed for skin and liver cancer trials

Bayer Pharmaceuticals and Oryx Pharmaceuticals say they have completed phase III patient enrolment for two trials using Nexavar, an anti-cancer drug, for therapies involving patients with advanced liver cancer and a separate group with metastatic melanoma, a common type of skin cancer.

The skin cancer trial will involve approximately 250 patients whose disease is continuing to progress following previous chemotherapy treatments of dacarbazine or temozolomide. Patients will receive Nexavar or a placebo, in addition to the standard therapies of carboplatin and paclitaxel. The effectiveness of the new drug will be studied with the intended result of patients surviving with the cancer no longer progressing.

For patients with advanced liver cancer, the effectiveness of the drug’s effect on survival times will be measured by comparing the time from symptom progression to tumour progression with the matching placebo. Around 560 patients will take part in the trial in America, Europe, Australia and New Zealand.

Henry Fuchs MD, executive vice-president and chief medical officer of Oryx, said: “Therapy with Nexavar could potentially provide an important advancement in the treatment of these difficult diseases, and we are pleased to have reached these milestones.”

He added: “While the studies are still ongoing and analyses will not commence until the pre-specified number of events are reached, we look forward to generating randomised data in these indications.”

Nexavar is a multi-kinase inhibitor which is currently approved for use in patients with advanced kidney cancer.

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