ImClone 'Eager' for Erbitux Data Release

The more benign explanation is that Morgan Stanley's analysts are reading something negative into a comment apparently made by an executive with the German drug firm Merck KGaA at a recent Morgan Stanley investment conference.

This Merck executive said that the FLEX study did not need to show a significant benefit on progression-free survival (a secondary endpoint in the study) in order for Erbitux to be approved or successful as a lung cancer treatment.

Responding to that remark, Morgan Stanley's European drug analyst Andrew Baum wrote in a May 6 note: "Our interpretation of these remarks is that FLEX may have failed to show a significant improvement in PFS, despite showing a significant improvement in overall survival."

So what if Erbitux doesn't show a PFS benefit, isn't survival all that matters?

Yes, survival is No. 1, but still, a survival benefit in favor of Erbitux without a corresponding PFS or response rate benefit will look a bit odd and might muddy the story. We'll just have to wait to see the data.

Did Johnson or Rowinsky say anything to tamp down these investors concerns?

I asked, but neither man wanted to comment directly on PFS or response rate data in the FLEX study. What they did say repeatedly was that they're eager for everyone to see the data and for them to be able to discuss openly how they intend to move Erbitux into the lung cancer market.

Is that genuine optimism or two company men doing a bit of pre-ASCO spin control?

Ha! A bit of both, I reckon. But then, we do know that there is a survival benefit in the FLEX study and that the ASCO decision makers gave the study a primo plenary presentation spot. Would ASCO do that if Erbitux's survival benefit was wimpy and unsupported by anything else on the efficacy side of the ledger? I guess it's possible, but it doesn't seem very likely to me.