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