Yesterday, Bristol-Myers Squibb (BMY) released inconsistent results for its colon cancer drug Erbitux (cetuximab) from two late-stage studies. Among the two retrospective analyses of the pivotal phase III studies, CRYSTAL and COIN, one reported positive results while the other failed to meet its primary end point. Erbitux is sold by Merck KGaA, Eli Lilly (LLY) and Bristol-Myers Squibb.

CRYSTAL is a multi-national study conducted by Merck KGaA. Erbitux, when added to Folfiri (a chemotherapy regimen) increased median overall survival to 19.9 months in an intent-to-treat population of first-line metastatic colorectal cancer (mCRC) patients compared to 18.6 months in the recipients of Folfiri only.

Moreover, when studied in a subset of mCRC patients with normal or wild-type version of a gene called KRAS, the median overall survival increased to 23.5 months in patients who received Erbitux plus Folfiri as against 20 months for those who took Folfiri alone.

The other study, COIN, was conducted in the UK by the Medical Research Council. The study did not find any overall survival benefit in combining Erbitux with chemotherapy as a first-line treatment for metastatic colon cancer patients having a particular genetic profile. The overall survival was 17 months in the Erbitux arm compared to 17.9 months for just chemotherapy.

Erbitux was tested in both the studies as a primary treatment for metastatic colorectal cancer. The drug is currently approved as a secondary treatment for colorectal cancer. It has also been approved for treating head and neck cancers.

The market for epidermal growth factor receptor drugs is currently dominated by Erbitux. Drugs in this class block a protein (epidermal growth factor), which facilitates cancer cell growth. Erbitux’s 2008 sales came in at $1.6 billion, about 10 times more than Amgen’s (AMGN) Vectibix. Both drugs compete with Roche’s Avastin that blocks blood supply to tumors.

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