ImClone 'Eager' for Erbitux Data Release

What does ImClone say?

I spoke with CEO John Johnson and Chief Medical Officer Eric Rowinsky on Monday afternoon. Neither man could discuss the actual FLEX data, of course, but both sounded confident going into ASCO.

"People are losing sight of the fact that, today, Avastin has about a 17%-18% share in the first-line [lung cancer treatment] setting," said Johnson. "Approximately 50% of patients are not good candidates for Avastin, so there is a tremendous unmet medical need in this setting, and that is a tremendous commercial opportunity for us."

Rowinsky added that the key thing that sets the FLEX study apart from the study upon which Avastin was approved is that FLEX was essentially an all-comer, real-world trial, enrolling patients with all of the different subtypes of non-small-cell lung cancer, patients with good and bad performance status and a wide degree of co-morbidities like heart disease and hypertension.

"When doctors, especially doctors in the community setting, look at the FLEX study, they will say that my lung cancer patients are in there," said Rowinsky.

I thought the FLEX data were embargoed until the ASCO meeting. How can Morgan Stanley make such bold -- and bearish -- forecasts on data that's under wraps? Shouldn't I believe the ImClone guys, since they've actually seen the data, over some analyst who hasn't?

Well, most worrisome is if Harr and his crew found an investigator in the FLEX study who was willing to blab about the embargoed data. Of course, if that's the case, they're not telling, but nothing surprises me with ASCO data -- ever. Leaks can and do happen, especially as we get closer to the conference. But for the record, I have not heard of any specific FLEX data leaks, just a lot of rumors.