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Celldex Therapeutics, Inc. Message Board

  • long_vrts2 long_vrts2 Nov 16, 2012 1:57 AM Flag

    Rindo 3 year survival data presentation at SNO'12

    Rindo trial results continue to impress:

    1. The comparison between ACTIII results and updated, matched RTO0525 data is the most relevant. Rindo showed a ~6 months median OS advantage over SOC, and a doubling in survival rate at 3 years (26% vs 13%).

    2. "This improvement is well within the bounds of what we anticipated when we designed our ongoing Phase 3 randomized ACT IV study and provides further confidence in the ACT IV study design.” This refers to whether the trial is sufficiently powered to show a statistically significant difference between Rindo and control. The answer is yes, and even if the difference between Rindo and control were to shrink to half of what it is now, it would still be significantly different.

    3. Long term survivors at 5 years: a significant percentage of these long term survivors are unmethylated MGMT/EGFRvIII+ pts. The prognosis for these pts with current standard of care is dismal: median OS of 6-7 months, with no survivors beyond 2 years. The fact that with Rindo, many of them are surviving at 5 years, and beyond, with apparently no progression, is definitive evidence of the clinical benefit of Rindo in this pt population. Were all else to fail, Rindo would still be approved for the unmethylated MGMT/EGFRvIII+ subset of pts, because it prolongs OS, and it literally is a life saver for many of these pts who currently have no other treatment options!

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