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GTX Inc. Message Board

  • jasper_schaible jasper_schaible Aug 20, 2013 3:02 PM Flag

    Enobosarm..where do we go from here?

    For the US, GTx hit 1 of 4. For the EMEA, they got 3 of 4. But they missed the key SCP in Power 2. Had they gone 2 for 4 with both SCP under the EMEA SAP, there may still be cheering in Memphis. Now it is all questions.

    But the survival signal is new info, so it allows the reg agency's cover to look at the package with fresh eyes. If they will or not is anyone's guess.

    The hope now may be for the US to permit a sec 901 accelerated approval path. The FDA has checked the box on unmet medical need, so they should allow that conversation. GTx hope is now pinned on the agency to consider LBM as a surrogate endpoint for survival. And there is some scientific rationale for such (Martin et al, etc.) so the FDA may be obliged to permit if linked to a PhIV study to test this hypothesis.

    So there is a chance the FDA will permit accelerated approval here but with a large ph IV study requirement to validate LBM as a surrogate for overall survival. It will be hard for the FDA to ignore the survival signal w/ the low side effects, given how difficult is has been to show any benefit with other triplets. And all this just might depend on the QoL and other tertiary endpoints. Recall agents like afatinib have been approved based on PFS vs standard of care even as it has yet to show any benefit on OS.

    So I suspect a redo of the Power 1 protocol, perhaps with more pts (Power 3?), or perhaps breaking the same n into two smaller trials. One exactly like Power 1, and another with newer agents like afatinib (Power 4?) as this is the kind wrinkle the FDA loves to toss in so they get more info. A 2nd hit on Power 3 in SCP alone should allow EMEA to green light even w/o any OS benefit.

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