Erbitux fails in gastric cancer trial
pharmafile | July 6, 2012 | News story | Research and Development, Sales and Marketing | Erbitux, Merck Serono, Roche, failure, gastric cancer
Merck’s Erbitux has failed to increase survival in patients with gastric cancer, representing a blow to the firm’s ambition to extend its licence.
The Phase III EXPAND trials assessed Erbitux (cetuximab), in combination with cisplatin and capecitabine, as a first line treatment for patients with advanced gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction.
But Merck said that its trial did not meet its primary endpoint of extending progression-free survival (PFS), and also failed to increase overall survival, the secondary endpoint of the study.
Dr Annalisa Jenkins, head of global drug development for Merck Serono, said: “Understandably, these results are disappointing for patients with advanced gastric cancer, and as a company we will continue to invest in oncology research and development to find new treatments for these diseases with high unmet medical need.”
Erbitux is currently licensed to treat colorectal cancer and squamous cell carcinoma of the head and neck, and works by inhibiting the EGFR protein.
It is also seeking European approval to treat non-small cell lung cancer in patients who overexpress EGFR.
The drug made €214 million in the first quarter, but a new licence in gastric cancer could increase its prospects.
Erbitux’s chances have been dealt a blow, but if it can reach the market it would be competing with Roche’s cancer drugs Herceptin and Xeloda in gastric cancer.
Gastric cancer, also known as stomach cancer, is the second most common cause of cancer-related death among men and women throughout the world, leading to over 700,000 deaths each year.
It is the fourth-most commonly diagnosed cancer behind lung, breast and colorectal cancers, with around one million people diagnosed in 2008.
The incidence of stomach cancer varies geographically with more than 70% of cases occurring in developing countries, and half the world total reported in Eastern Asia (mainly China). Incidence rates are also about twice as high in men as in women.
Ben Adams
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