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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.
I think 3 patients were recruited to the SCIB1/Keytruda (pembrolizumab) arm of the trial. So could be 24 patients recruitied to the SCIB1/doublet CPI arm and 3 to the SCIB1/Keytruda which gives the total of 27. Or Violindog may well be right and it could be 27 recruited but only 24 dosed.
Looks like recruitment has slipped again. Originally it was meant to be complete by end of 2023 then it slipped to Q1 and now it's Q2.
Violin,
Yes, that would make sense. It says 27 enrolled and 24 dosed. So 3 enrolled but not dosed.
I must admit, I struggled to make some of the numbers add up.
The other puzzle for me is the assertion that there is a 90% chance that the 85% ORR in the small sample of 11/13 will be repeated in the full 43. Whilst there is grounds for optimism there is no guarantee that these results will be repeated. If the 85% IS repeated in the 24/27, then the chances of repeating in the 43 will improve. But how the 90% figure is arrived at I have no idea.
27/43...so another 16 pts to be recruited by the end of June .
Empty...I get 13pts in the first stage of the trial with 11 responders....then the article says ...
"The SCOPE trial is in its second stage, with 27 of 43 total patients now enrolled. Recruitment is expected to conclude in the second quarter of 2024, and additional data are expected in the fourth quarter of 2024."
Yes the article says "Twenty-four patients have now received SCIB1 as part of the study." Perhaps the other 3 of the 27 have been "recruited" but not yet dosed ???.
27 patients enrolled and 24 have had SCIB1. And the other three?
Fingers cross for a good RNS tomorrow or Wed....it has to happen eventually :-)
Hopefully all the housekeeping RNS ‘s are out not good for blood pressure at 7 am
And a beefed management team . we should be on track at least AS news arrives on any of the following. With cancer vaccines hitting prime time 🕰️
Good luck to all for tomorrow and The presentation by the CEO
Yes, an impressive list and alot to hope for ...guess our fate depends on the timescale of delivery and the subsequent SP reaction.
In 7914 : "I had left out Moditope and Avidimab. If we get any significant news from either then that's a bonus."
Plenty to wait for then . . . .
Thanks to Bermuda, his 7909 over there:-
"Here are some items of potential news. Some are obviously much more important than others but in terms of building the flow of positive news could still contribute:-
1) Recruitment to SCIB1 cohort of current trial complete and last patient dosed
2) Confirmation that the 70% threshold has been met and therefore this arm of the trial is a success. If the ORR is maintained at 85% then that would be fantastic but I hope expectations won't be raised too high - the 70% is enough.
3) Presentation of these results at ASCO (would also be good to see participation at ESMO too)
4) Progress updates from the iSCIB1+ cohort
5) Recruitment complete for iSCIB1+
6) Top line results for iSCIB1+
7) Confirmation that pre IND meetings with the FDA have taken place and were successful thereby giving a clear development pathway forwards for SCIB1/iSCIB1
8) Clearance of IND and MHRA approval for the phase II/II SCIB1 trial
9) Details of the investigators for the phase II/III - particularly if Scancell have managed to secure any big US names
10) Confirmation that Genmab intend to take Scancell's mAb into the clinic and clearance of the IND. This should trigger a milestone but much more importantly it validates the Glymab platform for any others who may be evaluating other mAbs
11) Further Glymab deals
12) Addition of new mAbs
13) First patient dosed in phase II/III trial
I'll stop there. As I said earlier, the big unknown is what happens re. the Redmile CLNs and whether they can get a decent funding away. Certainly it will be easier if they manage to deliver on the above."
Good stuff ! Thanks again Bermuda . . . .
Hi Bazooka, thanks. I venture we've seen that before . . . then as now, it seemed odd to me that CFO is going, as it does seem to be a scientific conference. The "VP Head of Business Development, Oncology R&D, AstraZeneca" is also sitting on that Panel?
Also just to note that Sath as CFO and Prof. Lindy as CEO are shown as the only Executive Directors for Scancell now that SA has moved on.
Good luck to Sath at the Chicago Waldorf ! And GLA.
Https://www.linkedin.com/posts/sachs-associates-ltd-_sachsabroif-inperson-online-activity-7186732638345322496-f0gj?utm_source=share&utm_medium=member_desktop
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Co-Chaired by:
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Niranjan Sardesai, Founder, President & CEO, Geneos Therapeutics, Inc.
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And RR that was stated in the original RNS as a maximum - I very much doubt they'll get the full amount albeit not impossible it's unlikely particularly when only £5.3m has been received to date.
TF,
You say
"'I agree very much with your 01.42 re. the motivation behind all his posts."
Just out of interest, could I ask what your motivation in posting is?