FLEX: Erbitux Boosts Survival Five Weeks

CHICAGO -- The combination of ImClone Sytems' (IMCL Quote) cancer drug Erbitux plus chemotherapy boosts patient survival by five weeks compared to chemotherapy alone, according to results from a closely watched lung cancer study that were released a day early at the American Society of Clinical Oncology (ASCO) annual meeting Saturday.

A five-week survival benefit for Erbitux from the so-called FLEX study straddles most investor expectations, which were generally in the four-to-six week range.

The Erbitux survival boost, however, came close to missing the threshold for statistical significance -- an indication that while positive overall, suggests some data from the FLEX study are not as strong as they could be.

Whether or not ImClone shares get an immediate lift from the new Erbitux lung cancer data remains to be seen, and will likely depend, first, on how doctors and other cancer experts gathered here at the ASCO meeting react to the presentation of the full FLEX data later this afternoon.

Regardless, ImClone executives feel strongly that FLEX is Erbitux's ticket into the lucrative front-line lung cancer treatment market.

"This is the first study in which an EGFR [epidermal growth factor receptor] inhibitor has produced a survival benefit that is both statistically significant and clinically relevant," said ImClone's chief medical officer, Eric Rowinsky, in an interview Friday afternoon. "We succeeded where many others have failed," he added.

ImClone shares closed Friday at $43.50, down from a 52-week high of $49.18 reached just at the end of April.

The FLEX Study: Results, Statistics

The FLEX study was conducted by Germany-based Merck KGaA, which sells Erbitux in Europe. Patients with newly diagnosed non-small cell lung cancer were randomized to receive chemotherapy (cisplatin and vinorelbine) plus Erbitux or chemotherapy alone.