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Exelixis, Inc. Message Board

  • hbomb57108 hbomb57108 Feb 12, 2013 11:01 PM Flag

    Tivozanib updated phase 3 survival results

    "At the median, the difference in survival was just two weeks. Tivozanib-treated patients reported a median overall survival of 28.8 months compared to 29.3 months for Nexavar patients.

    However, when overall survival in the study was analyzed over two years, the relative risk of death was 25% higher in the tivozanib arm relative to the Nexavar arm. [Hazard ratio = 1.245.] While survival trended against tivozanib, the greater risk of death was not statistically significant."

    It will be interesting to see if Exelixis incorporates a crossover in planned 2nd line phase 3 RCC setting.(Somewhat disappointed in crossover on phase 2 ISP 1st line RCC study with sunitinib) I sure hope they can avoid it. Not a big fan of Tivozanib anyway, already enough similar VEGFR targeted approved therapies already.

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    • Thanks for the news. The interesting thing about this compound is how similar it looks to Cabo when you stare at its chemical structure. The seemingly small differences must have a huge effect on how strongly it binds to c-met receptors and hopefully its overall efficacy.

    • "It will be interesting to see if Exelixis incorporates a crossover in planned 2nd line phase 3 RCC setting.(Somewhat disappointed in crossover on phase 2 ISP 1st line RCC study with sunitinib) I sure hope they can avoid it."

      It's getting hard to keep it all straight, but I thought that the planned pivotal RCC trial was going to be a frontline trial and the HCC trial was going to be 2nd line. Now that EXEL is going to do pivotal RCC and HCC trials this year, I wonder if IST's in those indications may not happen. It seems like that may be a duplication in effort that would best be avoided??? I'm groping a bit, so if you know something don't be shy about stepping on my toes.

      • 1 Reply to erniewerner
      • "It's getting hard to keep it all straight, but I thought that the planned pivotal RCC trial was going to be a frontline trial and the HCC trial was going to be 2nd line. Now that EXEL is going to do pivotal RCC and HCC trials this year, I wonder if IST's in those indications may not happen. It seems like that may be a duplication in effort that would best be avoided??? I'm groping a bit, so if you know something don't be shy about stepping on my toes."

        I seen a slide from one of last year's presentations that displayed the 2nd line phase 3 trial in RCC. I believe Mike mentioned that Cabo was going to go against an active comparator, and that they were leaning vs sorafenib. Archival is difficult, especially trying to find slides.(past presentation slides are likely not available anymore) I might just quickly scan some prior seeking alpha transcripts to find.

        Yeah, I don't think IST 2nd line HCC trial is going to happen anymore. I forgot to look in latest presentation to see whether it was mentioned on slides. Exelixis website doesn't show any current plans in HCC.(You can see upcoming plans that are not on clinicaltrial site on the EXEL website)

        I'm guessing that Exelixis wants to do the 2nd line in Renal to get on the market faster. The IST first line would serve to show that Cabo should be moved up to earlier setting to compete with sutent and votrient. I like the rationale. I just don't know if Exel will have to run a phase 3 trial if IST is positive. I'm guessing the crossover will make it easier to recruit in 1st line setting, but a little worrisome to have crossover mess up a potential good look at OS.

 
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