cytodyn doesn't exclude kras.  which is good.  we want

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ScoreCarder twinter11 #161179
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cytodyn doesn't exclude kras.  which is good.  we want cytodyn to hit every mss-mcrc subgroup.  gives us more shots on goal.   i say mcrc because we require metastais in this trial.  but almost all rr mss are metastatic anyway.  the main dividing lines are LM (liver mets) vs NLM (non liver mets) and then KRAS/NRAS (RAS mutations) vs RAS wild type (no mutation).  would be great to see 30%+ ORR overall and also in KRAS.  less than that would be ok too, as the competition is so thin currently.  adagene is headed to p3 next year for NLM and could perhaps reproduce their 30% ORR.  cytomax is perhaps 18 months behind cytodyn, working on preliminary p2 trial design after hitting 30% overall including liver mets in p1.  

leron just needs to soundly beat the single digit SOC ORR to be on solid ground.  20% to be comfortable i would say?  but 30%+ would provide a lot more leverage and be comparable to anything that i can find in development.  

if you look into it, you'll find some very high ORR for MSS out there, but that's in earlier lines of treatment and using what are referred to as 5-FU regimens.  once a patient is refractory to those, the options completely suck.  cytodyn is trying to fill that nasty unmet need in third line therapy.   

here's a snapshot of what it all boils down to for mss-crc patients: 

  Treatment Line
Median PFS (Durability) Median OS (Survival)
First-Line 8 – 11 Months 26 – 32 Months
Second-Line 5 – 7 Months 12 – 14 Months
[color=rgb(0, 0, 160)]Third-Line 2 – 4 Months 6 – 10 Months[/color]

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