Lilly and Merck suffer a bit of a setback with disappointing Erbitux results

Unimpressive figures on patient survival further narrow the scope of colon cancer drug that once held much more promise

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INDIANAPOLIS & DARMSTADT, Germany—Eli Lilly & Co. and Merck KGaA's drug Erbitux, which is approved for advanced colon cancer, delivered disappointing results in a recent study aimed at expanding the use to patients whose disease is in an earlier stage.

However, when administered along with chemotherapy treatment for patients with stage 3 colon cancer, no survival advantage was demonstrated. Worse, it also significantly increased the adverse effects of the chemotherapy.

Researchers hadn't expected this, given that Erbitux had shown value in treating patients whose cancer was metastatic, and so many had assumed it would have value at an earlier stage like stage 3. In fact, researchers and analysts had largely assumed that it would be even more effective in stage 3 patients.

Previous research had shown that Erbitux was ineffective in patients with a mutation in the KRAS gene, so the recent study included only patients who lacked this mutation. Despite this precaution, there still was no improvement in evidence. When Erbitux was given along with the chemotherapy drug Folfox, patients showed a 72 pecent rate of survival without recurrence of the disease, compared with 75 percent for a control group receiving only Folfox.

With these results coming so close on the heels of the failure last year of Avastin, from Roche, in treatment for early-stage cancer, some are wondering if biologics are useful in early-stage colon cancer cases—both Erbitux and Avastin are biologics.

The news is also disappointing for Lilly and Merck after last year, when the prescribing information for Erbitux was changed to say that patients whose tumors have a mutation related to KRAS aren't helped by the treatment. That adjustment pretty much ruled out the drug's use in some 40 percent of colon cancer cases.

"Maybe it didn't live up to some of the initial hopes or expectations, but at the end of the day it still is an important drug that clearly is benefiting a proportion of patients," notes Steven Alberts, lead researcher in the recent Erbitux study and professor of oncology at the Mayo Clinic College of Medicine in Rochester, Minn. "It is a meaningful drug in the metastatic setting; just not in the earlier setting. The hard part is to figure out why it happened. That's the focus of our research now."

Erbitux had sales of about $1.4 billion lastyear, according to IMS Health, a drug research company.

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