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Msg  1735 of 1739  at  3/19/2021 6:45:37 PM  by

auh2oman


 In response to msg 1734 by  raferjack
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Re: The Aftermath ...

Well, I respectfully disagree. The DCR was 34.5% for the combination where as it was 27.2% for ipilimumab alone. That's a 7.3% difference, certainly better than no better. Below is from the FDA regarding clinical trial endpoints for Cancer DRUGS AND Biologics:
 
 Objective Response Rate • Generally assessed earlier and with smaller sample size compared with survival studies • Effect on tumor attributable to drug(s), not natural history • Generally based on objective and quantitative assessment • Definitions vary among studies • Frequent radiological or other assessments • May not always correlate with survival
 
Complete Response • Generally assessed earlier and with smaller sample size compared with survival studies • Effect on tumor attributable to drug(s), not natural history • Generally based on objective and quantitative assessment • Definitions vary among studies • Frequent radiological or other assessments • May not always correlate with survival
 
ProgressionFree Survival or Time to Progression • Generally assessed earlier and with smaller sample size compared with survival studies • Measurement of stable disease included • Generally based on objective and quantitative assessment • Potentially subject to assessment bias, particularly in open-label studies • Definitions vary among studies • Frequent radiological or other assessments • Balanced timing of assessments among treatment arms is critical • May not always correlate with survival
 
 
The key is Overall Survival (OS).What the Company does going forward regarding that all important endpoint in the Illuminate-301 Trial is very much still in play. I respect your opinion as well and the many quality posts over the years. I too have been here a long time and will to stay for the foreseeable future. All the best raferjack.


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Replies
Msg # Subject Author Recs Date Posted
1736 Re: The Aftermath ... raferjack 2 3/19/2021 8:37:30 PM
1737 Re: The Aftermath ... clsm 0 3/22/2021 6:48:22 PM


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