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ONYX Pharmaceuticals, AŞ Message Board

  • newcomer1235 newcomer1235 Jul 30, 2012 4:10 PM Flag

    DECISION (Thyroid) nexavar trial results?

    Any idea when the DECISION (thyroid) phase 3 trial results for nexavar may be out? The data collection was to end July 2012. Does phase 2 trial data give any hints as to the probability (high/med/low) of meeting primary endpoint in phase 3?


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    • Answer from the cc Q...

      Our next question comes from Navdeep Singh from Deutsche Bank.

      Navdeep Singh - Deutsche Bank AG, Research Division

      Just a couple of quick questions. Do you have any updates for the design of the Kyprolis Phase III trial and the newly diagnosed population? And secondly, I think you've updated your timelines for the readout of the DECISION trial to be in Q4, can you describe how you would -- you're thinking of this opportunity and why this trial is taking much longer to read out than previously expected?

      N. Anthony Coles

      Okay. Barb, would you mind taking those 2 questions?

      Barbara Klencke

      So the DECISION trial, I'll take first, and data is expected in the fourth quarter of this year. Why? It is an event-driven analysis. Our Phase II data showed something like a 96-week median time to progression-free survival, and so one might hope but cannot tell, until we do that analysis, that the treatment arm with Nexavar could be longer than what the study was minimally powered to detect. With regard to the first line trial, what we have said is that we are in the process of developing that trial and speaking with health authorities in the coming months. We've mentioned that it is likely to be a head-to-head, so we have VELCADE-based, carfilzomib-based treatment arms, but we've not finalized our plans at this point.