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Exelixis, Inc. Message Board

  • csanderson1805 csanderson1805 May 4, 2014 2:41 AM Flag


    Does anyone care to handicap the approval Cabo in the CRPC market. Obviously the market isn't too optimistic at this point unless there is a deliberate attempt to keep the price down. I am particularily interested in the opinions of Wilder, Ernie, onodoc, duck, enabler. I am leaning towards 65%

    Sentiment: Strong Buy

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    • I'm leaning towards 75% likelihood of Comet 1 success. Xofigo is why I'm more optimistic. Pain palliation is clearly a factor in OS. While the Xofigo Phase 3 patient population (patients with no known visceral disease) was a much healthier bunch, pain and QOL clearly have an effect on will to live. Remember Xofigo has no soft tissue efficacy. Cabo is a better treatment. Comet 1 will hopefully prove this out.

      Sentiment: Strong Buy

    • 50% / 50% This would be a higher price if it were more and lower if it were less.

    • $$$$
      "Does anyone care to handicap the odds of Cabo approval in the CRPC market?"
      I feel confident telling you that the odds of ultimate approval are 90%,but don't confuse that answer with my having said that an OS endpoint derived from The Comet-1 trial is necessarily the endpoint that will drive that approval. Should Comet-1 fail it's primary OS endpoint, I have confidence that at some point in the near future, we would see a pivotal trial designed to yet another approvable OS endpoint, quite possibly derived from a biomarker defined CRPC patient group of a trial designed to stratify and enrich a Cabo-sensitive treatment population. I've often said Cabo needs a CDX, and a Comet-1 failure would reinforce that point.
      I encourage you to read:"End Points and Outcomes in Castration-Resistant Prostate Cancer: From Clinical Trials to Clinical Practice" by Dr Howard Scher, et al. Dr Ethan Basch is a co-author. It discusses at length the need to distinguish between clinically meaningful outcomes that produce unequivocal patient benefit vs treatment decisions with outcomes based solely upon regulatory approval. This document provides guidance for the treatment of CRPC, incorporating treatment validation via biomarker assays, PRO's, and QOL considerations. Fact is, cabozantinib confers patient benefit in CRPC when other treatments cannot. It's already seeing off-label use in this indication. Not much, but it's there. Why? Simply because it works for some patients. Define that most receptive patient group and you virtually guarantee a successful trial outcome. This would reduce the commercial success of Cabo in CRPC by limiting the qualifying patient group, but I think a measure of clinical adoption is inevitable in this indication, regardless of how approval may be achieved. The labeling would simply reflect that an OS advantage had only been proven in a selected patient group, and warn against prescribed use outside that defined group. Hope this helps...GL

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