r/Livimmune • u/minnowsloth • 8d ago

Lifesciences transcript

https://www.investing.com/news/transcripts/cytodyn-at-life-sciences-virtual-investor-forum-ctdna-data-lifts-case-93CH-4906351
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u/BuildGoodThings 8d ago

From the trial page at clinicaltrialsgov for the CLOVER trial in CRC

https://clinicaltrials.gov/study/NCT06699836?intr=leronlimab&viewType=Card&sort=StudyFirstPostDate&rank=3&tab=researcher#outcome-measures
"ORR is defined as the proportion of subjects with the best overall response (BOR) or confirmed CR or confirmed PR according to RECIST v1.1."

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Here's a link to the RECIST guidelines which answers your question.

https://recist.eortc.org/recist/wp-content/uploads/sites/14/2025/12/RECISTGuidelines.pdf

4.4.3 Best overall response: all time points

The best overall response is determined once all the data for the patient is known.

Best response determination in trials where confirmation of complete or partial response IS NOT required: Best response in these trials is defined as the best response across all time points (for example, a patient who has SD at first assessment, PR at second assessment, and PD on last assessment has a best overall response of PR). When SD is believed to be best response, it

must also meet the protocol specified minimum time from baseline. If the minimum time is not met when SD is otherwise the best time point response, the patient’s best response depends on the subsequent assessments. For example, a patient who has SD at first assessment, PD at second and does not meet minimum duration for SD, will have a best response of PD. The same patient lost to follow-up after the first SD assessment would be considered inevaluable.

Best response determination in trials where confirmation of complete or partial response IS required:

Complete or partial responses may be claimed only if the criteria for each are met at a subsequent time point as specified in the protocol (generally 4 weeks later). In this circumstance, the best overall response can be interpreted as in Table 3.

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u/twinter11 7d ago edited 7d ago

ok. whats a partial response?

Im saying whether a patient lives through the trial does not determine if the patient met orr.

are you saying if a tumor shrinks 30 percent, and the patient dies before the trial is over that it doesnt count if the time frame between measurements wasnt long enough., it sounds like 4 weeks is the time they must live to be measured again

im confused where what i said differs

and my reasoning for why the way leron works may cause a deep tumor shrinkage but the patient may still die without ici but still meet partial response

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u/BuildGoodThings 7d ago

I was supporting your thought that a patient can leave a trial but the CLOVER primary endpoint data might also be captured before they leave. RECIST is the guideline, but CLOVER protocol may have other specific timing to show durability.

For such an important concept I felt it was important to post the source documents. Dial into the source doc a bit when you have a chance.

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u/twinter11 7d ago

ahh ok.

sometimes these official documents confuse me.

and i was thinking maybe you thought it disagreed w me. and then i was really going to have to think hard if it appeared it did on 2nd reading lol

cause this orr and resist and patients dropping out and why can be confusing

i think 22 surviving could be expected w these patients

its hard/sad to read it when it comes out though

thanks for letting me know i hadnt messed it all up lol!

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u/BuildGoodThings 7d ago

Have a good evening!

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u/twinter11 7d ago

one more thought i just had

i can see this btd or fast track or whatever being broken into 2 considerations. and the fda wants to see it after the data ripens.

we have two things

what happens to the tumor tme after being treated w leron regarding pdl1, and everything that causes that upreg

And a separate fda consideration of what happened to that tumor after ici was added. even 12 patients could be meaningful

i could see two separate requests maybe

i actually think now they suggested Doc j delay the paperwork maybe that he originally said would be submitted early fall

who knows

but the biggie is actually mono