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OncoGenex Pharmaceuticals, Inc. Message Board

  • bioprogene bioprogene Nov 20, 2013 9:11 PM Flag


    The P2 trial that produced 7 months survival advantage is not balanced between the two arms (it was a non-comparative trial anyway). The control arm had too many patients died within the first 12 months. The most telling statistics come from the "time from disease progression to death". In the P2 trial, the treatment arm gave a median of 18 months, whereas the control arm only produced a median of 10 months. The recent large clinical trials on CRPC are amazingly consistent, especially the medians from the control arms. The median from various second line treatment trials ranges from 10 (Yervoy) to 13.6 (Xtandi); however 13.6 is an outlier. 10 (Yervoy, 9/22/2013), 11.2 (alpharadin), 11.5 (OGX-011 and pred), and 10.9 (Zytiga, second line) are very consistent, with an average of 10.9±0.65 months. In general, median time from disease progression (from docetaxol treatment, front line) to subsequent treatment is 2.5 to 3.5 months (from progression to enter clinical trials: 3 months). Therefore, the median survival from disease progression (after front line docetexol treatment) to death should be around 14 (3 (from progression to treatment)+11 (10.9 average for the median)) months. In the phase 2 trial, in the docetaxol with OGX-011 arm, the median from disease progression to death is 18 months. Since there is no difference in PFS, the overall survival advantage should be close to 4 months (18 minus 14). My projection for synergy trial (final survival) would be (months) 25.5 (control) and 29.6 (treatment) with HR of 0.72 and p=0.019. The PFS would be (months) 7.5 (control) and 9.2 (treatment) with HR of 0.86 and p=0.063.

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    • I dont know what your background is but you sound like you did your homework.

      However, I see no way you can came up with projections that specific. IMO, it reduces your credibility.

      • 1 Reply to summer2762
      • You are absolutely right. However, if you struck your neck out for a projection, why not struck all the way out. Evidently I made a lot of assumptions in order to plug everything into the software to run the statistical simulation. I think the 4 months survival advantage is going to be very close (Phase 2 second line trial supports the assumption as well (15.8 months for OGX-011 plus docetaxol and 11.2 for OGX-011 and mito, assuming OGX-011 only works well with taxol derivatives). The next assumption is that only 35 to 40% patients respond to clusterin suppression (using clusterin overexpression for immune evasion, the rest use other pathways. I conducted extensive review of the literature to arrive at this number). The third assumption is that the survival curve start to separate at about 8 months (most immunotherapies). The projected median survival are 25~ and 29~ months. With the above assumptions with a typical CRPC population, the overall survival p value is about 0.04 at 18 months median follow-up ( interim?) and 0.02 at 27 months and 0.01 at 36 months. I put all the numbers spitted out by the software in my projection.

    • This is a thoughtful assessment. I do think it is worth noting that the multivariate analysis "disagrees" with your contention that the arms in the Phase 2 were unbalanced, against the control arm. The multivariate HR of .49 vs the unadjusted HR of .61 would argue that there was an imbalance in the opposite direction.

      Not trying to start an argument -- just noting that.


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