Another Study From ImClone Shows Mixed Results for Erbitux

ORLANDO, Fla. -- ImClone Systems (IMCL) released results Sunday from a late-stage clinical trial for its experimental cancer drug, Erbitux, that showed some positive trends, but that nonetheless, failed to meet the study's predefined clinical goal.

The data from the phase III study of 123 patients with advanced head and neck cancer were a mixed bag. The good news: Patients responded to Erbitux. The bad news: The study was too small to show a statistically significant benefit.

These results are considered the most important test of Erbitux discussed so far because the clinical trial is randomized and controlled, or more scientifically rigorous than previous Erbitux studies. This clinical trial was also conducted by an outside, independent group -- the Eastern Cooperative Oncology Group.

These results come just one day after ImClone released disappointing results from an earlier clinical trial of head and neck cancer patients.

In the study detailed Sunday, half of the 123 head-and-neck cancer patients were given Erbitux and the standard chemo drug cisplatin. The other half were just given cisplatin. The trial's investigators hoped to show that patients in the Erbitux arm would show a doubling in progression-free survival to four months, compared with just two months in the control arm. That means patients taking Erbitux would go twice as long before their cancer got worse.

When the data were analyzed, however, investigators found "no meaningful differences between the two group in terms of progression-free survival or overall survival," according to a press release issued by ImClone at the ASCO conference.

The problem: Patients in the control arm performed better than expected because the standard of care for head and neck cancer patients has improved since the clinical trial was designed. The clinical trial was also underpowered, which suggests that more patients might have helped improve the results, according to the investigators.

Erbitux performed better when judged against one of its secondary endpoints. Just under 23% of patients in the trial responded to Erbitux, compared with just over 9% of patients on chemo alone -- results deemed "marginally statistically significant" by the investigators.

"While cisplatin-based chemotherapy remains the standard of care for patients with advanced head and neck cancer, our results suggest that further evaluation of [Erbitux] is warranted in these patients," said Dr. Barbara Burtness of Yale University, and the study's lead author.

The results from this phase III study were released to the public Sunday, but they will be discussed in more detail at a presentation on Tuesday at the ASCO conference.

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