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Exelixis, Inc. Message Board

  • wilderguide wilderguide Jun 2, 2013 5:10 PM Flag

    Webcast surprise

    $$$$
    I think Mikey's gonna pull a wabbit outta his hat...
    GLTA

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    • I love it, an encouraging conference:

      1) pre-chemo low dose Cabo combined with abi or other was mentioned and discussed, it can certainly expand cabo on mCRPC market.
      2) Low dose Cabo with 60 mg for mRCC, I wonder if Chris from The Kidney Cancer Chronicles still on high dose Cabo?
      3) 10.8 months OS is encouraging, It was mentioned that COMET 1 population is very similar to current trial. There was no mention about the subpopulation, Do I miss anything here?
      4) high grade urothelial carcinoma co-existing with prostatic carcinoma.; in this group, Cabo is the king here, and cabo is the only choice.

      Sentiment: Strong Buy

      • 1 Reply to metropath
      • "There was no mention about the subpopulation, Do I miss anything here?"

        You did not miss it. You are asking a good question and with biotech, you have to pay attention to what's missing, so let's get that out of the way. We are talking about the 30+ patients who were both abi and chemo refractory and wondering about the OS for this relevant subgroup. The fact that it was not broken out, leads me to believe that it was not a statistic that EXEL considered positive. Other things missing were Dr Scher and we have never seen the results of the Ovarian NRE. There was not an update on the previously presented RCC 25 patient cohort. Last year the reported PFS was 14.7 months and OS not reached. Those data have matured and could have been reported.

        This ASCO was less informative that previous years', but that has to be expected. The clinical trial program is fairly deep into phase 3 trials and news flow slows down. The RDT was a big data generator with 9 tumor types tested, and nearly all of that news is out. Regarding the holes in the overall picture, there are a few present, but I do not see any of them as alarming. The CRPC community is not as easily wowed as they were by the initial BSR phenomenon and there is a kind of a "what have you done for me lately" attitude set in. Abi, MDV, and Alpharadin have sucked up most of the enthusiasm and until we get Comet results, that is the way it will stand. Frankly, I am more sanguine about the RCC and HCC commercial opportunities than I am about the initial CRPC market.

        Let's not forget that EXAM OS data will come out sometime in the not to distant future and the RET driven NSCLC trial will get underway. I also predict that there will be additional RET fusion driven cancer subsets discovered in other indications.

    • I think that the emphasis given to the bladder cancer indication is a bit of a surprise. The trial results will be presented tomorrow, I would not be surprised to see an accompanying press release is those results are significant. It was also interesting to hear the presenter emphasize that it was a significant commercial opportunity for the company that can get the first drug approval.

      It was also interesting to hear the RCC guys so willing to predict a positive outcome for a trial that is only just starting. They actually were more confident and less inclined to hedge than CRPC group has been over the last few years. I wonder if we could turn the clock back a few years and give management the opportunity to choose again the first pivotal trial programs if they might have decicded differently.

      • 2 Replies to erniewerner
      • It would have been a perfect decision in light of AVEO's failure (which is probably why they decided to stay away in the first place). There is also lot of competition brewing with Nivolumab showing excellent results in RCC, but there's no theoretical reason why Cabo shouldn't be first to market and shouldn't stack. There are also safety concerns for Nivolumab which could delay its introduction as they research an indicator for those who best benefit from it:

        "The most common side effects of treatment included fatigue, rash, and diarrhea. Other less-common side effects, such as fever, were consistent with the activation of the immune system. Five percent of patients in the trial targeting PD-1, and 6 percent in the trial targeting PD-L1, stopped receiving treatment because of severe side effects, and three patients who received the PD-1 targeted drug died of uncontrolled lung inflammation, called pneumonitis, caused by the treatment.

        'The pneumonitis is a safety concern,' said Dr. Camidge. And finding a method to predict which patients are most likely to benefit from these agents will be essential to justify both the risks and expected costs of any licensed immune therapy, he added."

        PD-1 blockers may be much more of a threat to the Vemurafenib + GDC0973 trial as Roche is starting a trial which combos its own PD-1 blocker with Vemurafenib and Nivolumab + Ipi is showing such promise in melanoma.

      • OT:

        " I wonder if we could turn the clock back a few years"

        I wish that were possible & MEDX was still a public co. What would IPI value add to MEDX today?

        That was a bitter pill to swallow.

    • I doubt there will be any surprises. I just think they are extremely cautious and very moderate. Another thing I asked about at the A.S.H.M. was dilution. I told them I was very unhappy with the share value and all the dilution. Frank Karbe told me going forward they were fine and not to look for anymore in the near future. I wonder what near is to him? They all gave me the picture of confidence about Cabo and it becoming a franchise with merit and value. Was it a smoke screen? I sure don't know. i only keep my fingers crossed.

    • when does it start ?

 
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