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Celldex Therapeutics, Inc. Message Board

  • fansteman fansteman Nov 16, 2012 4:17 AM Flag

    SNO 3- and 5-yrs survival up-data and what it means

    My personal take:

    This will help their phase III efforts tremendously to open new centers around the world and to accelerate recruitment of patients into the existing active centers (planned 19 countries and up to 160 centers, acc. to Mr Marucci's recent investor talk)

    QoL will be very interesting to see in these long-term survivors

    IMHO: The fact, that all of these phase II trials had no randomized control arm is the only thing that keeps them from filing already now. However, we should keep in mind: the FDA has granted approval based on (multiple) single arm (e.g., response only) data in the past (more recently, crizotinib/Pfizer for a certain mut+ sub-pop of NSCLC) and I wouldn't exclude that CLDX and FDA are at least talking. In the event that they strike a deal with FDA, by the time the dossier is ready for submission and FDA concludes their review the on-going phase III would be close to fully recruited (fall next year). Thus, an expedited filing and review would not jeopardize legitimate medico-scientific interests in large-scale randomized, well controlled efficacy data.

    Once, approval is granted (early or post-phase III) to rindopepimut for EGFRvIII mut+ patients (about 1/3 of the GBM population) this will likely open the era of biomarker driven 1L market segmentation.

    A new Stardand of Care in the making!!

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