ORR in a trial without a control arm requires 2 consecutive scans showing >30% tumor shrinkage thru the second scan, with no new lesions elsewhere. that's at least 12 weeks and maybe even 16 weeks. durability is everything here, with the primary endpoint being ORR. leronlimab is working, they already demonstrated cancer cells being killed by mentioning the reduction is ctDNA etc. its working at week 1 and thus the cancer is looking for a way around it beginning at week 1. the cancer either finds its way around soon enough to hinder ORR or it doesn't. that's the whole ball game and certainly not an "extraneous issue".
and now the quite strong legitimate praise, which shouldn't be necessary. the drug works well enough with ICIs in tnbc for eventual approval. they'll get there eventually. it is also having anti-cancer activity vs MSS-CRC. it might prove to be a big deal for MSS-CRC and that might become known with the 2nd conference data release at the end of may. anyone holding CYDY could become rich this year if MSS-CRC trial data is strong...
but durability is important to understand for any serious educated investor. we know there is anti-cancer activity from leronlimab. no surprise there. but it also needs to sustain that impact against a difficult cancer in order to add patients to the ORR and be a winner vs SOC in MSS-CRC. or, it needs to prove synergy with ICIs and likewise attain ORR in patients.
and now the quite strong legitimate praise, which shouldn't be necessary. the drug works well enough with ICIs in tnbc for eventual approval. they'll get there eventually. it is also having anti-cancer activity vs MSS-CRC. it might prove to be a big deal for MSS-CRC and that might become known with the 2nd conference data release at the end of may. anyone holding CYDY could become rich this year if MSS-CRC trial data is strong...
but durability is important to understand for any serious educated investor. we know there is anti-cancer activity from leronlimab. no surprise there. but it also needs to sustain that impact against a difficult cancer in order to add patients to the ORR and be a winner vs SOC in MSS-CRC. or, it needs to prove synergy with ICIs and likewise attain ORR in patients.
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