Erbitux meets gold standard in rectal cancer
pharmafile | June 7, 2011 | News story | Research and Development, Sales and Marketing | Erbitux, Merck Serono, rectal cancer
Studies of Merck Serono’s Erbitux in rectal cancer have shown improved overall survival, a gold standard measure in oncology trials.
Erbitux (cetuximab) increased overall survival by 5.1 months (22.5 vs. 17.4 months) in KRAS wild-type positive metastatic colorectal patients with non-liver limited disease.
Around 70% of metastatic colorectal patients (mCRC) patients develop this more advanced form of the disease, where the cancer has spread from the liver.
The phase III CRYSTAL study was being tested as a first-line therapy, in combination with chemotherapy agent Folfiri, and was presented at the ASCO cancer conference in Chicago.
In addition, the Erbitux combination therapy increased liver limited disease (LLD) patients’ ability to undergo surgery that could potentially cure the disease, known as a complete resection (R0).
The highest R0 rate was seen in patients with LLD treated with Erbitux plus Folfiri, but even though it saw a 2.58-fold increase in the chance of R0 versus CT alone, this study failed to reach statistical significance.
Professor Claus Henning Köhne, lead author of the ASCO publication from the Klinikum Oldenburg, Germany, said: “For most patients with advanced cancer, the chance to live longer, or even be cured, are the most important benefits a treatment can offer.
“These new findings from CRYSTAL are therefore important for both LLD and non-LLD patients, as we have a strong sign that both groups benefit from Erbitux combination therapy.”
Merck added that Erbitux in mCRC helps show the “value of personalising cancer care via a stratified medicine approach”.
Erbitux is licenced in Europe to treat EGFR expressions of metastatic colorectal cancer, and is also approved for locally advanced squamous cell carcinoma in the head and neck.
In 2008 the drug received an additional European licence to treat the KRAS wild-type mutation in colorectal cancer.
From these indications, the drug made Merck 820 million euro in 2010, an 18% increase on its performance in the previous year.
Merck is also seeking a further licence for the drug in EGFR positive non-small cell lung cancer, and is currently awaiting a decision from the EMA.
Ben Adams
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