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Danish biotech Evaxion published phase 1 clinical trial results for their personalised cancer vaccine EVX-01 today - see link below. The results are for patients with advanced inoperable melanoma receiving CPI in the first line setting. This is the same setting as the SCIB1 study although the Evaxion trial is in combination with a single PD-1/L1 checkpoint inhibitor as opposed to the doublet therapy for Scancell's trial. Nevertheless there are some interesting comparisons to be made
1) Evaxion reported an objective response in 8 out of 12 patients which equated to an ORR of 67%. This included 2 complete responses and 6 partial responses. As we know Scancell to date has reported an ORR of 85% (11 of 13 patients).
2) All but 1 of the Evaxion patients with an objective response subsequently progressed at a later scan with duration of responses of 2, 4, 5, 8, 9 and 10 months. We don't yet have this data for Scancell, as far as I know the latest update showed all 11 responses ongoing at 19+ weeks.
3) The Evaxion vaccine took between 6 and 8 weeks to manufacture but as it had to be administered on the same day as the PD-1 it took between 7 and 10 weeks for patients to receive their first dose.
Scancell does have the advantage of testing in combination with both PD-1 and CTLA4 CPIs and it's too early to compare duration of response, however given the cost and time to manufacture Evaxioin's personalied vaccine SCIB1 seems to more than hold its own in this setting. Have to stress that we need to see results for both vaccines in larger patient numbers but Evaxion's results do give some perspective I think.
Finally, in light of recent discussions please note that ORR is given as 67% (8/12 patients) and the timescale on clinicaltrials.gov is 3 years. Despite the fact that all but 1 patient had progressed, the ORR remained at 67% - if responders progressed at a subsequent scan the response was banked and it did not reduce the ORR of the trial. The same is true of the Scancell trial despite comments on this board.
https://jitc.bmj.com/content/jitc/12/5/e008817.full.pdf
https://clinicaltrials.gov/study/NCT03715985?term=NCT03715985&rank=1#study-plan
Thanks Berm...very interesting posting !
Now , I'm being a little thick I'm afraid....in your point 2) .... you mention "subsequently progressed at a later scan with duration of responses of 2, 4, 5, 8, 9 and 10"
Does this mean the patients cancer enlarged or shrank..? I'm not good @ the 1 % Club either š¤£
Violindog,
It means that having previously responded and demonstrated shrinkage their tumour(s) had started growing again.
Thank you Bermudashorts...all clear now !
Berm, et al... thinking about the very original Scib trial it gives one confidence our vaccine will both shrink and hold the cancer at bay.
Goodbye?ā¦I doubt that is truthful!ā¦but I live in hope!
Scinv,
I do give consideration to every post and viewpoint - yours being no exception.
Whilst you may well have a point (I don't understand enough about trial protocols to make a judgement) what I DO know is that Bermuda would not deliberately be dishonest. If he had someone wrong who would readily admit it.
So when you call into question the honesty and integrity of one of the most respected posters you just reveal yourself as a bullying egotist.
Ruck, couldn"t agree more. I said exactly the same thing in a post to Scin_v, which he responded to last week.
Another respected poster here. posted a cryptic message here last week as to his true identity, not sure if you saw it, but it called him out as being our dear old friend Knowlesi.
Since being out of here I can read into any negative comments without wearing rose tinted glasses, but I must say his posts IMHO are designed in their repetitive and innaccuricies just to be disruptive.
As you always used to say, just ignore them if you feel the same. Hope you are doing well buddy, can"t believe we are all 12 years older than we were when we invested and posted here to begin with!!!!
ATB.......C7
I see you had ny comment on how it actually works deleted. A behaviour all too familiar from people who don't care about facts. Bermuda is either not familiar with how this works (therefore he mislead you about being an expert) or he is an expert and has an agenda. You decide.
Read below
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8183261/
And the general guidelines from NCI (note the .gov in the link before you say anything silly)
https://ctep.cancer.gov/protocoldevelopment/docs/quickrcst.doc
This is what I wrote previously
Scinv_temp
Posts:Ā 1,207
Price:Ā 9.65
No Opinion
RE: Morning10 Jun 2024 08:52
4.5. Frequency of tumour re-evaluation
Frequency of tumour re-evaluation while on treatment should be protocol speciļ¬c and adapted to the type and sche- dule of treatment. However, in the context of phase II studies where the beneļ¬cial effect of therapy is not known, follow-up every 6ā8 weeks (timed to coincide with the end of a cycle) is reasonable.
[...]
Recist 1.1 guidelines
https://project.eortc.org/recist/wp-content/uploads/sites/4/2015/03/RECISTGuidelines.pdf
If you read the paper that Bermuda posted they report from the phase 1 part, not the phase 2. In addition, ORR is not in the primary or the secondary outcome of the study but in the "other outcomes" which are exploratory.
Isn't funny that Bermuda only lets you reply to me but he never does himself and also refuses to admit that he has nothing to do with biomedical sciences and that he is in fact a finance person?
(This IS goodbye IF my previous comment remains in place)