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Exelixis, Inc. Message Board

  • bking73 Dec 18, 2012 7:46 AM Flag

    OT but Onco related - Liver HCC


    Pardon the OT, but wish to reach out to Ernie, Oncodocs, hbomb and the other knowledgeable posters here on this topic.

    Given CNSL's phase 3 PFS results for ThermoDox treatment of Liver HCC will be read out sometime next month, what is your take on the PFS advantage of T-dox over RFA, especially w.r.t distant mets. It seems logical that there are some PFS advantages on local recurrence but distant recurrence seems to be a crapshoot. The bear take is that DRs occur on segments that are untouched by doxorubicin and hence there will be no significant difference between the treatment and control arms. Bulls argue that some of the distant recurrences are actually due to intrahepatic mets and blasting the tumor zone and the expanded perimeter with heat and high concentrations of doxorubicin destroys these perimeter tumorous cells and hence will show up as a significant DR benefit.

    Especially with respect to DR, do you believe that the science is there to show DR PFS benefits by this T-dox approach? Thanks much for your thoughts.

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    • Gotta be short, Y is censoring me today. CLSN did an interim at 190 events that failed. That means that whatever efficacy is there is modest. For reference, Comet final was at 138 events with miniscule p value. Market is voting against Celsion and T and market is usually right. Good luck.

    • I have a few observations and suggestions for you and that is it. I'm not really interested in Thermodox, and frankly I get annoyed when posters pump other other stocks on this mb. First, Celsion did an interim analysis at 190 events. It failed to show a statistical andvantage for the treatment arm. Interims come with a much more stringent requisite efficacy than final analyses, but 190 events is a large sample. For reference, the Comet final analysis was done at 138 events and had a miniscule p value. That tells you that if T does show a statsig final result at best it will be a single or double, no home run. The market is voting against T. The upside is to not expect a drop in price if the trial has statsig topline results, but the market is saying that the probability is low, and frankly, the market is usually right.

      Now for the suggestions. Figure out who the top liver guys are in the U.S. See if any liver guys are on ODAC and see who is on the HCC NCCN advisory committee. Figure out if any of these guys are publishing T data. If not, then virtually everything you can find out about T is probably coming from Celsion and the inventor of the process. If that is the case, it makes for a slanted story and it makes it hard to get an objective opinion from someone who has access to all of the data. Are there any randomized results or is it all single arm comparisons to historic data? These are suggestions and rhetorical questions, not an invitation to debate the drug or company. Good luck.

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