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Erbitux trial shows cancer drug has no benefit after surgery

Merck KGaA’s colon cancer drug no better than standard chemotherapy in study

Merck KGaA Erbitux colon cancer

Merck KGaA's colon cancer drug Erbitux has failed to improve outcomes compared to standard chemotherapy when given immediately after surgery in a phase III trial.

Erbitux (cetuximab) did not improve disease-free survival in the study when added to FOLFOX (folinic acid, 5-fluorouracil and oxaliplatin) chemotherapy, which has been the standard of care for just under a decade, compared to FOLFOX alone.

The trial involved 2,559 patients with stage III colon cancer, when the disease which has spread outside the colon to the area surrounding it, but has not affected other organs and is still suitable for surgery. Adjuvant drug treatment is often given alongside surgery to try to destroy any residual cancer cells.

"We are disappointed not to see an improvement in disease free survival after 3.3 years of median follow up," said Professor Julien Taïeb of the Hôpital Européen Georges Pompidou in Paris, who was the principal investigator in the study.

Erbitux is not the first new treatment to fail to provide any additional benefit on top of FOLFOX, he added.

Merck's drug is already approved as a treatment for metastatic colorectal cancer, and competes for market share among the epidermal growth factor receptor (EGFR) inhibitor class with Amgen/Takeda's Vectibix (panitumumab).

The latter has been gaining ground of late following approval for first- and second-line treatment of metastatic colorectal cancer in Europe.

Merck booked €855m ($1.1bn) from its share of Erbitux global sales last year, while US marketing partner Bristol-Myers Squibb said it made $691m. For comparison, Amgen reported Vectibix sales of $322m in 2011.

"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 Dr Annalisa Jenkins, head of global drug development at the pharma company's Merck Serono division.

Erbitux is also in phase III development in gastric cancer and was submitted in Europe last year as a treatment for non-small cell lung cancer.

The latter indication has however been dropped in the US by BMS and the drug's originator, Eli Lilly subsidiary ImClone Systems, after it was rejected by the Food and Drug Administration (FDA) earlier this year.

10th May 2012

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