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Hi Ciaskin,
I agree with your maths, it would need to be 28 out of 34 to maintain the 82% level. Scancell do occasionally give out conflicting information and I sometimes find it confusing.
I notice that page 9 of the interim results presentation in January’24 fits in with what you say as it makes reference to “more than 27”, it states:-
Simon stage 1 >8/15 ORR; Simon stage 2 >27/43 ORR
https://www.scancell.co.uk/Data/Sites/1/media/fininfo/2024/scancell-interim-results-fy-2024.pdf
Bajookajr’s link states 27 of 43 patients now enrolled, so agree another 7 patients would take this to 34.
I am no expert but I interpret (on the basis that when they got 9/11 ORR in Simon stage 1 they immediately moved to Simon stage 2, rather than waiting for results on 15 patients) that if they get 28 out of 34 that would be enough and they would not require results from 43 patients. AIMO
Thanks for reposting Johnny. What is slightly confusing for me is that while 9 out of 11 is indeed 82%, 27 out of 34 is only 79%. It would have to be 28 out of 34 to maintain the 82% level. Either way, is she saying that if we were to achieve the necessary ORR after just 34 patients dosed, then we wouldn't need any more before moving to/preparing a Phase II? If so, we would only need to recruit another 7 patients...
Abysmal.
Even manado keeps repeating his posts on the other side. Buying at 11p proved to be throwing good money after bad. And folks were queuing , it’s not under value , it’s exactly where it should be
So much excitement repeat of what was already in the public domain
No news as Scancell has a master in old news.
Q4 possible
Year ?
Same old news. Why I’m not surprised.
Surely they are not regurgitating results from a few months ago?? I accept they are trying to raise awareness at every opportunity but I can’t believe, given Lindy’s comments, it’s months old data…..?
This is a slow burner zzzz. Let's hope nobody leap frogs us.
A case has started in the High Court today in which Moderna is suing Pfizer-BioNTec for royalties on Covid vax sold after March 2022. The gist of the case is that Moderna claim that targeting of the spike protein is their IP, whereas P-B claim they made an inventive step with their vaccine. The case is expected to last 20 days.
I suspect the outcome may have a bearing on who is seen to be leading the mRNA field……and who may be left looking for an edge of their own.
Ipad......they had better be quick as it start's in just over 10mins
Next Tuesday, 23rd April 2024, Scancell Ltd CEO Lindy Durrant is presenting at the 8th annual Immuno-Oncology Summit Europe, hosted by Cambridge Healthtech Institute in London. Professor Durrant, will be speaking in the Therapeutic Cancer Vaccines program, where emphasis on clinical studies will be highlighted.
Lindy’s presentation, “Clinical Update on the DC Targeting Melanoma Vaccine, SCIB1 and the Modi-1 Vaccine Targeting Citrullination,” will take place from 2:45 pm – 3:15 pm BST sharing exciting results on SCIB1, Scancell’s ‘off the shelf’ ImmunoBody® #cancervaccine, which has demonstrated positive efficacy data from the Phase 2 SCOPE trial for advanced unresectable #melanoma, as well as Modi-1 as a monotherapy in range of hard-to-treat solid #tumours.
"Following on from #AACR24, there has been significant interest in the clinical development of therapeutic cancer vaccines, and I am excited to demonstrate the progress Scancell has made in this class of immunotherapies." - Professor Lindy Durrant
Many thanks Ray, JonhnnyB1, bazookajr those comments are really useful.
I'll have to work out how to use the binom.dist function in Excel.
ATB
If we want to find the probability of achieving at least a 70% response rate in a group of 43 patients, assuming our best estimate of the response rate is 82% (i.e. 9/11 patients had a response).
We model the number of responses X in 43 patients as X~Binomial(43, 0.82)
We then calculate the probability of having ORR > 70% i.e. P(X>=30), since 30 out of 43 is approximately 70%
If we plug in the numbers, the calculation shows that there is approximately a 96.2% probability of achieving at least a 70% response rate in a cohort of 43 patients, based on the initial success rate of 82% observed in the first 11 patients.
The 90% refers to the probability of repeating existing data. Page 10 of the 2023 AGM presentation states: “Greater than 90% probability of replicating this data in the full cohort of 43 patients .”
https://www.scancell.co.uk/Data/Sites/1/media/docspres/agm-presentation-november-2023.pdf
In the 2023 AGM presentation, Lindy says:-
“Again if you like your stats and I’m not going to argue stats with you because I’m not an expert, they tell me if I get 9 out of 11 responses there’s a 90% probability that we will meet that milestone of 27 out of 34 which is really exciting”.
https://www.youtube.com/watch?v=say9mRBFzCo
This is a fuller version of what Lindy says from about 6 minutes in, talking about metastatic melanoma:-
“Metastatic melanoma until very recently, probably five years ago was a death sentence, there was no therapies doesn’t respond to chemo, nothing works in metastatic melanoma. The double checkpoints have now improved that to 50% our intention was to improve that 50% t0 70% because the clinicians told us that would be a meaningful impact for these patients, but a really tough ask, there have been many combination studies in this area that failed to achieve that but we’ve got better than 70% as you can see we smashed it at 82%. So we were supposed to see 9 patients out of 15, we actually saw those 9 responding patients and I’ll show you that data, out of 11 patients. That’s an 82% response, even more exciting there was no toxicity associated with the melanoma vaccine. The checkpoints themselves particularly one of them can be quite toxic but the addition of the vaccine had no additional there at all which again is really good in combinations. So we now move to the second stage, so the first one we had to see 9 in 15, the second stage we need top see 27 responses in 43 patients, or if we see this 82% response rate it will be 27 in 34 patients. Today as we talked to you as its changed again there it’s 21 patients that have been immunized so we’re pretty much going down that route, we only have to get 34 so hopefully proably early next yearwe will finish that but you need to bear in mind they do need to be on the study for at least 3 months to that first scan when we get that first response to see whether they’ve got an objective response. So hopefully sometime in the next half next year we should get that data and see how good it is. Again if you like your stats and I’m not going to argue stats with you because I’m not an expert, they tell me if I get 9 out of 11 responses there’s a 90% probability that we will meet that milestone of 27 out of 34 which is really exciting”.
Ruck
"But I don't think we are privy to enough data to see how 90% confidence was arrived at."
I would guess that Lindy asked someone from the Maths department at Nottingham Uni about the probability of success.
She herself stated that she was informed of the probability but she didn't know how the figure was calculated.
But I do think that SCIB1's chance of success is higher that Burnley's chance of avoiding relegation 😒
Ruckrover,
“ Yes, that would make sense. It says 27 enrolled and 24 dosed. So 3 enrolled but not dosed”
Not necessarily. iSCIB1+?
Definitely a 99% probability that 99% of posters have 0% interest where it came from.
Bermuda, Moonparty,
Many thanks for the response and clarification.
Even so, regardless of whether success is 85% or 70%, where does the 90% confidence come from?
My job involves working with probabilities. To achieve a 90% confidence level (assuming a normal distribution), you would need 1.28 standard deviations. But deviation from what. I guess if we had the %responses for each individual patient in the 13 measured to date, we could work out the standard deviation and apply 1.28 times this to the arithmetic mean. We could then classify the results and work out the numbers for complete response and partial response and see if this is over 70%.
But I don't think we are privy to enough data to see how 90% confidence was arrived at.
One live Chanel
22nd of April 24 - ( Linked to relevant content )
Vishal Patel, MD, FAAD, FACMS, associate professor, Dermatology, George Washington (GW) School of Medicine & Health Sciences; director, Cutaneous Oncology Program, GW Cancer Center, discusses the evolving use of PD-1 inhibitors for patients with cutaneous squamous cell carcinoma (CSCC) in the neoadjuvant and adjuvant setting.
https://www.onclive.com/view/dr-patel-on-the-evolving-use-of-neoadjuvant-pd-1-inhibitors-in-cscc
Just rambling now, but this could be a normal distribution (with response rates) or a binomial (with binary response / no response). I used to understand this stuff when I was at Uni!
But I see your point about how they calculate / what the 90% means, and Bermuda has eloquently summarised.
If anyone can remember the stats / normal distribution equations, we could probably calculate the percent chance of 85% or higher response rates in the whole population.
RR, it's probability theory - the greater the sample size (number of patients with results) the higher the chance it is representative of the population as a whole.
Ruck,
Have just read the rest of your last post. This is what Scancell actually said about the 90% figure:-
'The aim is to achieve at least 18 further responses (i.e., 27 responses in total) which would statistically demonstrate that SCIB1, in combination with doublet therapy, exceeds currently achievable ORRs. Recruitment is on track with data available in H1 2024. Based upon the first 13 patients there is a greater than 90% probability that the second phase will also be successful.'
So they're not saying that there's a 90% probability that the 85% will be repeated in the full 43, they're saying that there's a 90% probability that the trial will be successful ie. reach the 70% response rate threshold.