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Yes, great results in a new, significant indication, even if there is still a long way to go for value to be realized. The Japanese market will help in the intermediate term, and, IMO, the fact that they aren’t targeting oncology is a major, if not decisive, advantage from an investment perspective. Time will tell on that front.
The ARDS results also confirm that cell approaches are the way to go in treating diseases with complex, interactive pathways versus the single target approaches (doomed to fail in a curative sense in most cases, IMO).
Lol - even the pre-announced time of the presentation is up for debate.
Got it - thanks for helping dot the i’s.
Additional thoughts on this phase 1b neoantigen trial, the results of which may be implications for DCVac.
Thanks Flipper - that makes sense, otherwise they would be short-changed on the treatment.
Presumably this means that treatment arm patients who progressed and chose to stay on treatment also restarted the schedule to avoid braking the blind?
Doc, i checked the trial info on clinicaltrials and didn’t see an answer to this question- seems like you might know.
Treatment and control arms received their injections on the same schedule — more closely spaced to begin with, then tapering off to a regular, widely spaced schedule. What happened when a control patient progressed if they were in that later part of the injection schedule that was evenly spaced out — did they get their DcVax-L injections at the pace they had been receiving placebo (ie, spaced out) so that they wouldn’t know they had been on placebo, or did they in essence start over and get the DcVax-L injections closely spaced and then tamper off again? This second option seems like it would unblind the patient, at least locally to the doctor and the crossover patient.
TIA
Hi Ike,
Just voting for six questions -
1, 4, 6, 9, 10, 18
Thanks for your efforts!
Thanks Gus! Good stuff in itself and also triggered reflections on ways to effectively present complex info.
Hoping they do after top line is announced
Hilarious Homer clip and representative of AF’s analysis of trial data, in my book. What’s missing is what I speculate are his mercenary motivations. Perhaps Ben Afleck in Boiler Room? This scene could be AF breaking in a new group of biotech analysts—
Ha! Though I suspect Stupp would do it with resentment, not as a celebration of his friend’s success. Hope I’m wrong on that (Stupp’s feelings about DCVax).
Extremist - great of you to post the full text- thanks!
The devil is in the details...
One more thought — not sure how MD Anderson ranks in GBM but I assume they’re near the top. Based on my experience reading deeply on cancer treatment options, it’s the best overall of the big four (Sloan Kettering, Dana Farber and Mayo being the other three). MDA is just as up-to-date as the others but it seems to foster out-of-the-box approaches more than the others. Inside-the-box hasn’t worked as well as we would have hoped.
On the other hand, the other three may have something cooking, specific to their institution that they’re looking at that is promising as well.
Obviously general statements from an anonymous poster on a mb — grab salt and sprinkle liberally.
ae, the Stupp interview that Senti posted has some relevance to your friend who was his diagnosed with GBM.
Thanks Senti - always worth hearing what ol Stuppy has to say on Glioblastoma, even if it must be put into context with some salt at the ready. JMO
Neoantigen vaccine generates intratumoral T-cell response in Phase 1b glioblastoma trial
https://www.nature.com/articles/s41586-018-0792-9
Nice detail around IDH and implications for treatment - thanks Flipper.
Bevacizumab seems to have turned out to be a bit of a bust (though I don’t doubt it’s making billions). I know I had high hopes. Would be glad to be proved wrong on that if anyone one feels the need to post survival data. Actually would be thrilled to be proven wrong since an effective drug would be pretty useful!
I remember reading early phase results back in 2002? in which a couple of patients died and others had intestinal ulcerations or some such AE. Don’t remember how Genentech got around that - dosage maybe?
I think we are in agreement on FDA putting the cart before the horse on safety vs whatever efficacy there is/might be with regard to the slew of quick approvals of ICIs.
Be that as it may, patients are now faced with the issue wading through the known data and making a choice to use a particular ICI if it is available for their cancer. Unfortunately many will go along with their onc’s recommendation in the absence of a meaningful conversation about the patient’s risk/reward tolerance or other relevant health priorities, etc.
Nothing related to cancer is easy.
Great sources Xena! Dr M’s site seems especially good - thanks for sharing it!
Agreed Survivor regarding single target vs whole tumor lysate approach. But if Rindo had pushed out PFS for three months in a statsig way, the company would have had a “winner.”
I plan on making the case from a “theoretical” perspective in the future. I was going to end with “stay tuned” but was afraid people would start throwing things at me. I guess I did anyway!
Agree with your thoughts on chemo — unfortunately it is still widely used and most likely will continue to be for quite awhile. Obviously wish it worked better for more people. Regarding ICIs, it is still early days and much to learn about risk/benefits and best use. Certainly would consider it (and chemo for that matter) if it were applicable to a particular cancer I happened to have, but it’s a gift horse whose mouth I would scrunitize as well as I could.
Efficacious, well-tolerated. Reminds me of a quote from The Princess Bride:
Regarding issues with published research, which is related to Xena and LF reply in the related thread:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146194974
The Ioannidis article I linked to (“Why Most Published Research is Wrong) is of interest to be sure, but it’s heavy reliance on statistics make its potential audience significantly less than I intended. It’s theoretical nature also presents issues of interpretation and application that make it less valuable, in the sense of raising more questions than it answers.
The article I actually meant to reference was the following that discusses Amgen’s attempt to reproduce “landmark” preclinical research in oncology:
Appreciate the dialogue as well as your perspective and experience. Thanks for the tip regarding Venter’s autobiography.
Regarding me being right or wrong on journal hijinks in this particular case, I’m not asserting anything because I don’t know the details. I asked about it mainly because my interest is much greater than NWBO. The problem with that is that asking questions in a NWBO mb will be perceived by most as having some kind of agenda related to NWBO. Given the contentious nature of the mb, that is completely to be expected. I view things through that lens too. However, I’m finding a lot of value here from thoughts and questions that are triggered that go beyond NWBO. It’s been very fruitful and has generated much more than I can deal with — a great problem to have.
BTW, I also agree that it is unlikely that there are any issues with the article published on JTM. Liau strikes me as a first-rate scientist (judgement based on past experience with scientists, not directly with LL unfortunately).
That is not to say that scientific research should be trusted blindly. Economic, social, political and personal issues plague the endeavor to a highly surprising degree. As just a first approximation, you may be familiar with the work of John Ioannidis, a researcher who studies scientific research.
He wrote the paper “Why most published research findings are false:”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1182327/
It is one of the most referenced papers ever published. The implications are pretty far-reaching but I don’t want to think about them now because I want to go to sleep tonight.
Anyway, commenting on the success of the work, Ioannidis said:
"This probably only proves that citation metrics are highly unreliable, since I estimate that I have been rejected over 1,000 times in my life.“
Appreciate the reply, biosect!
It is ambiguous. I wasn’t aware of the particulars around the publication of the article. The use of the phrase by a CEO in public piqued my interest. I’ve found that seemingly minor things like that that for whatever reason capture my interest can led to unexpected insights or information if one tugs on the loose end. Many times not, or at least not right away. Of course, the sleeve of the sweater can end up on the floor. But that’s interesting in its own way.
Thanks for the lead, idunno!
Anyone else aware of “battleground” stocks that seem to be subject to such wildly divergent opinions and possible manipulation (presumably on both sides)? NWBO seems like an extreme case to me but if it’s going to happen, cancer-related stocks make sense because it is such a contested area in medicine.
Given the rigors of the peer review process, it is understandable that the desire to get things right takes precedent and could easily lead to delays. Liau knows this very intimately. It isn’t much of a leap to assume she explained this process to LP. Given that assumption, I find it of interest that LP would refer to the journal as “that damn publication,” especially in public. Seems like more going on there to me but that’s just speculation on my part. Hence, why I asked for more thoughts on it in my reply to biosect.
Thanks!
Any thoughts on “that damn publication?”
Thanks - I needed something to get my mind off the effect the fumes we’re having on me.
Looks very worthwhile to dig into.
Thanks for reposting the link to your notes on last year’s ASM and hats off on volunteering to honcho the gathering of the questions for this year’s meeting!
From your notes:
Ike- enjoyed reading your post, entertaining as well as some solid points made.
Senti, thanks for sharing your thoughts - it will help me begin to understand where some of you are coming from so I can at least follow the conversation and start to form a better picture of these issues.
Doc, I appreciate your reply — it cracks the lid on a couple of apparently widely accepted propositions I found particularly interesting after coming across this mb recently in my attempt to tune in more closely due to potentially imminent binary events. I’m a little concerned about pursuing these questions because I don’t want to open a box that generates a 500 post storm that essentially rehashes what I assume happened here in 2015/16. Maybe the answers are straightforward and no worries (fingers crossed):
Flipp, excellent point. Even approaches which we hope to make obsolete (like chemo/radiation) may play a legitimate, though limited, role in the future.
Personalized immunotherapy and cancer vaccines video
Video and transcript of a discussion held at ESMO 2018 meeting between Dr Ignacio Melero, professor of immunology at the Academic Hospital of Navarra and the Center of Applied Medical Research at the University of Navarra in Spain; and Dr John Haanen, chief scientific officer in immunotherapy and staff scientist in the division of immunology at the Netherlands Cancer Institute in Amsterdam.
They discuss various issues standing in the way of predictable efficacy in patients. Not sure if you need to sign in or not since I probably have an old cookie following me around.
https://www.medscape.com/viewarticle/906875?nlid=127135_4801&src=WNL_mdplsfeat_190115_mscpedit_honc&uac=22471CJ&spon=7&impID=1860580&faf=1
Longfellow, much appreciated that you went as far as you did trying to bring me up to speed on reading the tea leaves related to partially released trial results. As you point out, assumptions must be made at significant points along the way. My fear is that the error bounds on all these many points will fuzz up the final answer to such an extent that any signal will be lost in the noise. That intelligent analysts come to completely opposite conclusions doesn’t bode well for me, especially when there is disagreement on basic facts. That this becomes part of the house of mirrors around Nwbo shouldn’t come as a surprise, I suppose.
Regarding confounding - unfortunately can’t provide a sword to cut the knot there either but I came across an article which contends that crossover designs, contrary to the impulse that gives rise to them, are unethical because they may fail to answer the question that could have been answered clearly otherwise. You’re probably aware of the article since no small tidbit goes unnoticed or unanalyzed around here, but the idea had never occurred to me so I found it of interest. As Rumsfeld suggested, it’s the unknown unknowns you have to watch out for. Ironic referencing Rummy in the context of ethical choices but the guy had a way with words.
https://www.ncbi.nlm.nih.gov/m/pubmed/24365533/
That I found the author’s point worth taking into account doesn’t suggest much about my views on the clinical trial process as a whole. It seems to be operating as a barrier to entry more than anything else, but there’s a lot of “else” to consider too. As you know, the topic of trial reform is vast.
Keep up the good fight - patients need advocates who are aware of the depth and breath of the issues that prevent effective treatments from reaching them.