Merck KGaA announces mixed Erbitux trial results

Merck KGaA, the German pharmaceutical manufacturer, has revealed the results for two clinical trials for Erbitux, the cancer treatment, in patients with metastatic colorectal cancer.

In one of the trials (entitled Epic), the primary endpoint of overall survival was not met in a study comparing the use of irinotecan and irinotecan with Erbitux. Merck KGaA claims that this could be because patients in the irinotecan arm of the study who showed signs of disease progression were then given Erbitux with irinotecan.

However, the secondary progression-free survival and response rates to the drugs were “hugely in favour” of the Erbitux-plus-irinotecan patient group.

A different phase III study did meet its primary endpoint of overall survival in a trial that sought to compare Erbitux monotherapy against best supportive care, after treatment with irinocetan, oxalplatin and flouropyrimidines.

Dr Wolfgang Wein, senior president of global oncology commericalisation at Merck KGaA, stated: “The results of the Erbitux monotherapy study are extremely encouraging as they reflect the power of Erbitux to attack cancer cells and significantly improve patient survival when all other conventional therapies have failed.”

“This clearly differentiates Erbitux from other EGFR-targeting therapies that did not show a survival benefit in this setting,” he added.

Erbitux was the centre of controversy earlier this year after NICE decided not to approve the drug for prescription on the NHS to treat bowel cancer over doubt about Erbitux’s cost-effectiveness.