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OncoGenex Pharmaceuticals, Inc. Message Board

  • mr_ssssamsa mr_ssssamsa Nov 3, 2011 9:57 AM Flag

    MDVN scores with interim data

    Trial halted, pps has more than doubled:

    A little too rushed today to look at the results closely. In the long run this could help OGXI since it showed at ASCO that at least preclinically 011 enhances the efficacy of MDV-3100. Once MDV-3100 is approved Teva could in theory fund the development of combination trials, though they'd probably have to start with a P1 or P2 trial. Also, MDV-3100 will be approved in the post-chemo setting and Teva and OGXI might want to wait until it's approved for the pre-chemo space.

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    • Your understanding is correct.

      OBF=O'Brien Fleming. The most commonly used method/computation to decide whether a trial should be stopped early for efficacy or futility.

      I hope the co will start giving more info about the interim as we get closer to 2013.

    • You made the right decision. As a lawyer you probably don't use math much. And even if you still made the right decision.

    • I am starting to regret I chose typing over math in high school...but the girls sure were pretty!

    • One more observation related to OGXI in the discussions following the MDVN results is that analysts/bloggers/bboard posters pay more attention to the absolute difference in the median between the arms rather than the HR (not even % increase in median). They say MDV3100 is better because MDV3100 had 4.8m difference vs 3.9m for zytiga.

      This is not a valid point as MDVN clearly recruited healthier patients than zytiga trial did (10.9 vs 13.6m for control arm) and the HR is the same 0.63 vs 0.65.

      However, this mind set is good news for OGXI as OGX-011 may/can demonstrate a higher absolute difference in the median as it is given earlier in the disease progression.

      Also, MDV3100's early unblinding should emphasize my point that OGXI investors should plan their investment/trading strategy for the interim analysis which should occur in Q1 2013 (my estimate; not a guidance from the co).

      • 1 Reply to summer2762
      • Summer, please correct me if I'm wrong about what follows, as I know we've touched on it in an earlier exchange. I was under the impression that there's a difference between a prespecified interim analysis -- such as the ones that were done for MDV3100 and I believe Zytiga and the one OGXI announced Teva planned to do in the 011 lung trial before that was put on hold -- and the kind of interim analysis the DSMB routinely does in which they are looking primarily at safety data but also at evidence of efficacy. That is, I thought in the case of a prespecified interim analysis, either the trial will meet the interim endpoint and be deemed successful or, if it misses that endpoint, it will continue but there will be a penalty in the sense that a lower p-value (such as .025) will be required for success on completion. If there is no prespecified interim analysis, it's less likely the trial will be completed at interim but there is also no penalty. I wish I could remember where I'm getting this from or what the rationale for the penalty in the prespecified scenario is but I don't. Does any of this ring a bell with you? I just want to be sure we're not overestimating the odds of the SYNERGY trial ending early, so that if it doesn't we won't read too much into that.

    • MDVN now has a MKT CAP of $1.22B

      Not bad at all for a third line P3 postate drug.


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