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Exelixis, Inc. Message Board

  • wildbiftek wildbiftek Jun 12, 2013 1:14 AM Flag

    Seeking Alpha's Goldman Sachs conference transcript

    Some more color on the expectation for the control group my MMM:

    Mike Morrissey - President and CEO
    So that's a very I think straightforward overall cabo read-out. It will enroll 960 patients. The population is again post-Taxotere and either abiraterone or [enthulodomide] sequence. So a patient who gets, you know, Taxotere first and then, you know, say abi second, or [enthulodomide] first and Taxotere second would qualify for that study. To kind of give you a sense of our view of how that market is evolving, we want to have it be broad enough to be able to cover we think the eventual movement of both abiraterone and [enthulodomide] into the pre-chemo study.

    All that being said, the modeling was I think pretty straightforward. We used the abi arm from [COU-AA-301] to model our control arm, and then based upon a variety of different data, we had about 10 months overall survival, median overall survival for the cabo arm, you know, has a ratio modeled to be 0.75 [inaudible].

    So again, very straightforward overall trial. It's been up and running for a while now. We've got 225-plus sites up in Western Europe, US, Canada and Australia. So again we're not giving guidance, updates on enrollment, but we hope to have it all done and read out in 2014.

    Terence Flynn - Goldman Sachs
    Okay. So the 10.8 months from ASCO compares to 10-month projection --

    Mike Morrissey - President and CEO
    It's the net same in the end. Yeah, yeah. With all the caveats that go with it.

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    • Terence Flynn - Goldman Sachs
      I understand. Okay.

      And I guess in terms of the Phase 3 trials, are you excluding the patients that did (sic) alpha ratings, the latest drug to get approval here. Is that --

      Mike Morrissey - President and CEO
      No. We have no exclusion criteria for additional therapies, so they can have cavaxitaxel, they can get [provanes], they can get that, or other drugs. But there's no -- we're looking pretty broadly, which we think is important since that's kind of where the state of that treatment arm is right now, that treatment arm is now. So I think there's going to be a lot more movements going forward as more work is done in sequencing either in, you know, trials or just kind of through the experience of GU oncologists, but we think again cabo has got a pretty unique profile. If we're successful here, it could be a pretty important market for us.

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