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Really? How can this sentence be read in any other way?
'If there was a 90% chance of exceeding an 85% ORR then you can be certain that 85% would have been the target ORR, not 70%.'
Perhaps 'without saying as much' part could be the problem?
They wouldn’t.
I was just making the point that the 90% confidence in reaching 70% is driven by the 85% already having been achieved in one cohort - and noting (without saying as much) that it would be nuts to think they had a 90% chance of beating 85%.
You seem determined to get the wrong end of the stick today……..
Ee
The whole trial was designed and powered to produce a 70% response rate as that is the level which demonstrates that SCIB1 is having an impact (ie. 20% higher than CPIs alone) and merits further development. How/why could/would they change that to 85%?
Johnny,
It is the fact that 85% is “in the bag” from the initial cohort that drives the 90% probability of exceeding 70% ORR.
If there was a 90% chance of exceeding an 85% ORR then you can be certain that 85% would have been the target ORR, not 70%.
That said, as I pointed out earlier, the 90% number is irrelevant once the results start coming in…..indeed their internal expectations may already be different?
Bermuda,
Thank you for getting clarification on that, I appreciate it.
Johnny,
Yes I know and it was your post (thanks) that prompted me to email as this seemed to contradict the original RNS which I understood to read 70% - see my post of 23rd. I think the wording of that part of the AGM presentation was unintentionally slightly ambiguous and could easily be interpreted as the probability of replicating the 85% response rate whereas they actually meant the probability of successfully passing the 70% threshold as the first cohort had done.
Anyway at least we know now. It will be really good news if they hit that 70% response rate which will mean the trial has been successful and a bonus if the response rate is higher.
So where are we estimating for next ‘actual news’ update? Hard to gauge where things are really at, at the moment which is another minor annoyance on top of the indifferent levels of clear communication from the BOD. Keep on holding, keep on hoping :)
Hi Bermuda (and emptyend),
I don't doubt what you are saying but that contradicts what Lindy said at the AGM and what it states on page 10 of the AGM presentation (See my 12.27 0n 23 April).
When you say "Lindy has clarified ............... ", have you emailed her?
Yes that is correct.
And, as someone pointed out earlier. the 90% probability figure is meaningless once the actual results start coming in. The actual results may be better or worse than implied by the high confidence figure.
Thanks for clearing that up Bermuda
Johnny,
Just an update on the 90% probability of success discussion regarding SCIB1.
Lindy has clarified that it is the probability of achieving a 70% response rate, not replicating the current 85%. To be precise it's the probability of achieving a '70% ORR on 43 patients' from the current SCIB1 study.
Cleanerworld
The NHS won't be paying for Modernal's vaccine - Moderna will be paying the NHS to run their clinical trials.
Good find WTP
the 26 th of April The good law project are questioning Sunak relationship with his fund Thelme and Moderna. A £400,000 Bespoke vaccine per patient ( as the times are now calling it ) a 10 year contract / tie in with the NHS is questionable ? belt and braces measure, after surgery . So how much is the total cost ? tIt’s a very interesting debate. Please read this link.
https://goodlawproject.org/government-ordered-to-disclose-sunaks-hedge-fund-emails/#:~:text=Shortly%20after%20Sunak%20became%20prime,a%20financial%20interest%20in%20Theleme.
I knew it was expensive, but not that expensive?
"New £400,000 melanoma vaccine heralds start of 'cancer renaissance' as UK trials personalised jabs for lung, bowel, pancreas and liver tumours... but experts fear NHS can't afford them"
https://www.dailymail.co.uk/health/article-13353713/New-400-000-melanoma-vaccine-heralds-start-cancer-renaissance-UK-trials-personalised-jabs-lung-bowel-pancreas-liver-tumours-experts-fear-NHS-afford-them.html?ico=topics_pagination_mobile
Bermuda
I understand perfectly the point you are making. The two trials are different so we are not comparing apples with apples. The measure of 49% improvement over keytruda alone is a measurement that is irrelevant to the Scib1 trial results since keytruda did not figure in this trial.
However, given the fact that scib1 alone gave such outstanding results in the adjuvant setting, must surely be relevant information if and when a pharma is assessing scib1 overall. Surely any prospective partners would be thinking along the lines of conducting a scib1 or iscib1 trial in combination with keytruda trial in the adjuvant setting. This would be in addition to taking the current scope setting into a phase 3 trial.
“ Just matching the results of a personalised vaccine with an off the shelf solution should be enough.”……
…..correct. Very clearly we are not yet at the point of being able to compare like with like but it seems to me that achieving tumour shrinkage in unresectable melanoma is at least as relevant for treatment as an increased expectancy of non-recurrence of a tumour that has been removed. Especially if the costs are lower and the elapsed time to end of treatment is shorter.
CW...yes you'd think the likes of NICE/NHS would definitely prefer something off the shelf and far cheaper than the very costly personalised approach.
Thinking allowed the bespoke vaccine will take longer and be more expensive to produce. So could cause a significant delay
The off the shelf offering from Scancell could reach the required patient numbers quicker
Pros and cons of both vaccines.
Ray,
SCIBI has produced some fablulous results in the adjuvant setting albeit in small numbers in a single arm trial but as a monotherapy. The issue I have with comparing the 49% from the Moderna vax's with SCIB1 lies with that 49% fiigure. If it represented the RFS rate of the Moderna arm of the trial then I can see how you might start to make a comparison, but it doesn't. It's the improvement in the likelihood of a recurrence compared to the results produced by Keytruda alone. So in that trial the Moderna patients were 49% less likely to have recurrence compared to the patients on the same trial receiving Keytruda alone. We have absolutely no clinical results from SCIB1 to compare that with.
Moderna still have to a long way to go with this vaccine. There's the Phase 3 clinical trial itself, a double blind randomised study in just under 1100 patients and then there's the whole process of seeking approval with the various regulators. It will be fantastic for Scancell if they're successful and should Scancell ever want to revisit the adjuvant setting with SCIB1 it might even provide an easier path through to approval. Just matching the results of a personalised vaccine with an off the shelf solution should be enough.
From Inan on the other board...
"lets assume that moderna and merck get approval ...
and they become the standard of care
Opdivo and Yervoy left in the cold
Bristol Myers being a poor relative losing business thinks ....
we want that market .... SCIB1 tested with our product is stunning ...
Ok .. make a move"
On sky news as well
Just noticed the headline has changed in The Times from :
Skin cancer jab trial targets high-risk melanomas
New headline
Bespoke cancer vaccine targets tumours in landmark trial
https://www.thetimes.co.uk/article/e23343c5-91c4-49b0-9fa4-c1eec5c2bb2c?shareToken=
They are discussing the MRNA skin cancer vax btw
Good listen. I have whattsapped them about SCIB1. Expect to be ignored!
Bear in mind that there has already been a clinical trial for SCIB1 on it own (i.e. without checkpoint inhibitors) in the adjuvant setting.
The numbers were small in the trial and the delivery method was different to that of the current SCOPE trial.
However, the famous swimchart is testament to the high level of success in this trial, albeit with the limitations stated in the previous sentence.
This will not escape the notice of pharma keeping their eyes on SCIB1 and iSCIB1+ results.