Merck KGaA’s colon cancer drug fails trial
pharmafile | May 16, 2012 | News story | Research and Development, Sales and Marketing | Erbitux, Merck KGaA, Merck Serono, colon cancer
Merck KGaA has suffered a setback with key brand Erbitux as the colerectal cancer drug failed in a late-stage trial.
Researchers were looking at Erbitux (cetuximab) in the adjuvant treatment of stage III colon cancer after surgical removal of the primary tumour, the idea being to destroy cancer cells that may remain.
But interim analysis of the Phase III PETACC-81 trial showed no benefit in disease-free survival for these patients given Erbitux plus standard chemotherapy (FOLFOX 4), versus FOLFOX 4 alone – dashing Merck’s hopes in this setting.
“While these results are disappointing, we continue to invest in expanding the science behind Erbitux to ensure its appropriate and safe use for patients living with cancer,” said Annalisa Jenkins, Merck Serono’s head of global drug development and medical.
Erbitux is already indicated for the treatment of patients with KRAS wild-type metastatic colorectal cancer – although NICE says it is not cost effective.
The drug is also licensed to treat advanced and metastatic squamous cell carcinoma of the head and neck, and last year studies in rectal cancer showed the drug improved overall survival, a gold standard measure in oncology trials.
PETACC-81 was carried out by the Fédération Francophone de Cancérologie Digestive (FFCD) in Dijon.
“We are disappointed not to see an improvement in disease-free survival after 3.3 years of median follow-up,” said PETACC-8 principal investigator, Professor Julien Taïeb from the Hôpital Européen Georges Pompidou in Paris.
“Unfortunately, since the introduction of FOLFOX as standard treatment, all attempts to further improve prevention of disease recurrence have proved unsuccessful,” he added.
PETACC-8 took 2,559 European patients – 1,602 of whose tumours were KRAS wild-type. The data will be available at future scientific meetings.
Recent research has suggested that stage II and stage III colon cancers show significant differences in the frequency of several key markers – indicating that the stages are actually different diseases rather than logical steps in a single cancer.
Colorectal cancer is the fourth most common cancer worldwide, with around 1.2 million cases and an estimated 609,000 deaths each year – more than a third of them in Europe.
Adam Hill
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