Bayer HealthCare and Onyx begin Nexavar phase III trials

A phase III trial of tablets as an additional systemic therapy for liver cancer was started this week by Bayer HealthCare and Onyx Pharmaceuticals, it has been announced.

Nexavar (sorafenib) will be evaluated as an adjuvant therapy for sufferers of primary liver cancer or hepatocellular carcinoma (HCC) using a randomised, double-blind and placebo-controlled system.

The drug was approved in Europe and the US at the end of 2007 for HCC and the new phase III study – Sorefanib as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma (Storm) – is intended to build on earlier data which found an improvement in patients’ overall survival.

Bayer said the trial will focus on around 1,100 patients, including those who have had surgery or related procedures to remove their tumour.

It will concentrate on whether recurrence is delayed and overall survival is increased when oral Nexavar is used in an adjuvant setting.

In other news, Bayer HealthCare recently announced the positive results of a phase II study investigating the treatment of patients with age-related macular degeneration.

Bayer and Regeneron Pharmaceuticals said the patients using VEGF Trap-Eye showed improvements at the 52-week marker. The drug was generally well-tolerated, Bayer said, with no related serious adverse effects.