This trial was all about safety, tolerability and dosing plans for phase 2. The trial endpoint was met. The group of 14 tolerated with no apparent worsening of tumors and most had tumour reduction 5:4.
What exactly happened to the other 6 is unknown. The list of possibilities is enormous: had another appointment on day 56, died, released they were cured and ran away...... I ponder what their true outcome was since they were not scanned and there is no control group. I guess we wait for phase 2. You could sell down now and wait for the usual post trial SP slump to buy back in. However, I will keep mine.
Of the 4 that were listed as stable, quite a range of outcome for this group - "Stable disease (RECIST 1.1) is when the total tumour burden that increases less than 20% or decreases less than 30%". This means this group actually could have had a positive outcome but by definition were stable.
The high study departure rate is a concern however, to have 5 patients show a partial response is absolutely fantastic. I wonder what dose the partial response group of 5 received. Would be interesting to know if this group all received the higher dose.
So much info they don't publish.
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