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CYTLIMIC positive results - YNP01 Phase 1 trial, page-6

  1. 601 Posts.
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    Efti in MBC - phase 3 = $20 million and 2-4 years. If Frederick can find reasonable grounds in sub-groups then its possible for a phase 3 trial to be funded, but not by Immutep (imo). Big Pharma may have a crack - MBC is difficult to treat and remains a high unmet need. Possible licensing deal - $upfront to cover our P1-2b costs and milestone/royalties.

    TACTI-002 is where the rub is - thus far Keytruda mono has a 20% response rate in NSCLC (80% of all lung cancer) The FDA’s initial approval of Keytruda (pembrolizumab)immunotherapy was based in part on data from the KEYNOTE-001 clinical trial,which initially showed that Keytruda alone had an overall response rate ofnearly 20% among previously treated and treatment-naive patients with advancedNSCLC whose cancers expressed high levels of PD-L1.Noting FDA approval for Keytruda in this setting is only for high PD-1 expression.
    Keytruda and Efti in NSCLC - 47% overall response rate. Admittedly small cohort BUT this is for allcomer PD-1 status....

    Patients by

    PD-L1 category

    No. of Responses

    iORR

    1

    Low (< 1%)

    1

    33%

    2

    Medium (1-49%)

    3

    50%

    3

    High (≥ 50%)

    3

    75%

    4

    Not evaluable

    1

    25%

    5

    Overall

    8

    47%

    Patients byPD-L1 categoryNo. of ResponsesiORRLow (< 1%)133%Medium (1-49%)350%High (≥ 50%)375%Not evaluable125%Overall847%

 
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