Exelixis, Inc. (EXEL) announced that the Independent Data Monitoring Committee (IDMC) notified the company today that a planned interim analysis of the COMET-1 phase 3 pivotal trial has been completed, and that the IDMC recommended the trial proceed to its final analysis. Exelixis continues to anticipate top-line data from COMET-1 in 2014.
Oh well, the interim news is barely moving the pps in after hours trading. My guess was a significant drop due to a missed interim analysis. I really hope the Zelboraf/Cobi data are released before the final COMET I data come out.
"OK, the waiting time might be shorter than I thought. Are they going to release some data on interim analysis tomorrow?"
I'm pretty certain this is all we are going to hear about the interim. I wish I had been wrong, but this is the outcome I anticipated and now we will see how well the market takes it. Here are the facts. More than 960 patients were enrolled with 960 attained right around 9/26/13. 387 have died and the final analysis will occur at 578 deaths, an additional 191. With the compressed enrolment, best guess is that we will see topline results in 8-10 weeks. Having failed the interim points to the HR running somewhat north of .70, but we will see the real numbers on down the road.
Next up will be the EXAM OS analysis which should be announced shortly.