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Celldex Therapeutics, Inc. Message Board

  • fansteman fansteman Mar 8, 2013 1:37 PM Flag

    Fast-to-market indication: reGBM

    Read between the lines:

    There was an important part in the Q&A when Boris Peaker of Oppenheimer asked them to discuss reACT in more detail. Data in recurrent glioblastoma will become available end of this year according to the stated 2013 milestones of the company. The discussion in the CC was around the question whether or not the phase 2 reACT trial could fulfill the criteria of a pivotal trial. And without ever really stating it clearly, they discussed the question what would make an acceptable, i.e filable sample size. In other words is the original 70 Avastin naive (35 on, 35 off rindo) and 25 Avastin refractory size big enough to file or would they need to expand the size and add more patients...

    Conclusion: There is - at least - a scenario where reACT is positive and filable and CLDX could be looking at recurrent GBM as their first to market indication for rindo with a launch as early as 1st HY 2015. First-line GBM in this scenario would become a mere line-extension (and would thus go much faster, too).

    Sentiment: Buy

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    • yes! this is a very important nuance you and I both picked up on. The upshot is that THE PLANNED INTERIM ANALYSES CAN RESULT IN PIVOTAL DATA TO SUPPORT EARLY FILING FOR APPROVAL, IF THE SMALLER DATASET USED IN THE INTERIM ANANLYSES SHOWS OVERWHELMINGLY POSITIVE EFFECT size strong enough to trump the lower power that the early readout brings with it. This is possible with these targeted treatments (like Rindo and CDX-011) more so than typical shotgun approach to selecting study patients as with most clinical trials, CAVEAT is that THIS IS BY NO MEANS ASSURED because of the much lower statistical power inherent in the intermin analysis sample size, BUT IT CERTAINLY IS POSSIBLE and will be looked at very carefully at the time of the interim data readouts

      Sentiment: Strong Buy

      • 1 Reply to mymandon
      • I am not aware of any planned interim analysis in the reACT study protocol, mymandon. We will be looking at the top-line final results YE'13!

        Of course, it's a phase II - but it's double blind.
        Of course, PFS is the primary endpoint - but in 2nd line, there is no approved treatment option and PFS in this disease is even more meaningful clinically for patients than in other malignancies. And PFS has been accepted by FDA in other cases - including Avastin in glioblastoma!

        Sample size, for me, remains the only big question mark whether or not a positive reACT read out would be acceptable for FDA. In today's environment of "breakthrough" pathways to registration, this small study may just be big enough.


        Sentiment: Buy

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