Study: Erbitux May Be As Good as Earlier Hoped

New clinical trial results for the experimental cancer drug Erbitux show that the drug, when combined with chemotherapy, shrank tumors in almost one in four patients with late-stage colon cancer, according to German drug company Merck KgaA.

The data from the Merck study, presented at the annual meeting of the American Society of Clinical Oncology, is almost identical to that gathered in a U.S. study by ImClone Systems back in 2001, when it said that 22.5 percent of advanced colon cancer patients receiving the Erbitux-chemotherapy combination saw their tumors shrink

The validity of the earlier study was called into question by the the U.S. Food and Drug Administration, which rejected ImClone's original application for Erbitux in December 2001.

Merck reported that in its European study of 329 colon cancer patients whose disease was progressing after failing to respond to the chemotherapy drug irinotecan, the combination of Erbitux and irinotecan shrank tumors in 22.9 percent of patients.

It said only 10.8 percent of patients taking Erbitux alone had a reduction in tumor size. That number is also very similar to what ImClone reported from a small study using Erbitux alone.

Merck last week announced it would use the new data to file for regulatory approval for Erbitux in Europe this summer (see earlier Colorectal Cancer Week story). While neither ImClone nor its U.S. partner Bristol-Myers Squibb has yet indicated when it plans to return to the FDA, the new data seems likely to spur patient demand for early reconsideration of use of Erbitux iln the United States.

Other Sources: ASCO