You here less about BionTech's mRNA colon cancer vaccine failure/discontinuation with poor outcomes. The media does not want to show case the unknowns and negativities associated with mRNA vaccines especially with viral season approaching. I have seen too much vaccine-induced autoimmunity or thrombosis in my days. mRNA covid shots will increase interferons about 280 fold which could be good if you have cancer. But a healthy taking it to protect against virus, you may have damage from the cytokine storm or miscarries but like Fauci, Murthy, and Walensky lets not tell the folks!!!! Vioxx got approved when I was a medical student. I'll never forget the tactics used to fool the people.
Perhaps you woke up in a cycle of unwarranted exuberant optimism.
1) The bespoke nature of the vaccine makes it personalized, which is both important, and also unlikely to be universally marketable (cost-efficient).
2) The biggest caveat is that this is melanoma-and extrapolation of findings from melanoma to epithelial malignancies is both unwarranted and injudicious.
3) As this moves forward in melanoma, one will find failures, because no limited biopsy will capture the full repertoire of bespoke antigens required for effective responses.
To my “amateur “ eyes, and compulsive nature, the stock price images are much more impressive due to the lack of a ZERO on the vertical axis? But that may be part of the churnalism?
Thank you for your thoughts on the nature of sensationalist reaction to the Merck/Moderna announcement of positive topline results from the Phase 3 INTerpath-001 trial. Having worked half my career in academic research and the second half in pharma, I can tell you that the conclusions in the press release will indeed be confirmed. That is not to say that it is a good practice, but honestly, the companies are restricted from providing more detail if they plan to publish the results in a good peer-reviewed journal where the results will be trusted.
I will note also that the "results" come from a pre-specified interim analysis. When reporting clinical trial results, companies usually have a plan that includes publication at the time of database closure. Here, I suspect the trial team was truly surprised that the primary and some secondary endpoints were already met. That is why they didn't have a publication ready to go. Hopefully, they will be getting the publication out ASAP.
Companies also need to provide topline summary in order to comply with government regulations. They certainly don't want results known within the company to leak and put the companies at risk to insider trading and other ethical problems.
If you look at the trial record (NCT05933577) in clinicaltrials.gov, you will find that completion of the primary endpoint was expected in October 2029, over 3 years from now. The fact that the data were statistically significant now offers a dramatic clue that the published results are also dramatic. Furthermore, the record shows that the enrollment was over 1000 patients and the clinical characteristics of those patients are defined, though obviously not the demographics.
Just one more thought about safety - the Phase II trial results were just reported at ASCO this year. Yes, it is very important to know whether the Phase III confirms the risk/benefit picture.
The real problem here is Wall Streets' reducing clinical trials to binary pivots as your graphic shows. But in this case, they are probably right.
To publicly traded companies, the stock price is everything. The press release was about money, not about medicine, and certainly not about improving patient care.
Shame on the mainstream media for noting it at all. In the old days of paper newspapers, it would have rated a column inch in the Business section. Maybe.
The stock trading done by algorithm-driven computers drove up the stock price of both companies in response to the press release, closely followed by retail investors chasing the next big thing.
Those of us who care about the treatment, and whether it makes a difference to melanoma patients will wait for the paper. And Sensible Medicine’s careful take on it.
Excellent article, Dr. Cifu. My brows did raise in wondering if public figures would be more likely to admit mistakes if they were not threatened for being wrong during very challenging times. And also thanks for the stock tips.
Second: this sentence from the opening paragraph is confusing me: “The combination therapy decreased recurrence-free survival and distant metastasis-free survival.”
The internet press release by the companies say:
“Patients given both treatments were less likely to have the cancer return or spread than those who received Keytruda alone, the pharmaceutical companies announced Wednesday.”
Should your sentence read “the combination therapy reduced recurrence and distant metastasis”, or “the combination therapy increased recurrence-free survival and distant metastasis-free survival” (increased the time of survival??)
Maybe because it’s 0500 I’m terribly confused and your terminology is completely correct.
Thanks for this post! The mRNA neoantigen therapy could be a great treatment—but as you said, we need to see the Phase 3 trial data in full! (Not yet released—do they have 70 years in which to do so? How expensive will this “made-to-order” injectable be????😬😬😬)
Nicolas Hulscher just posted this info about Vita C/DMSO combo being effective for skin cancers
https://lnkd.in/p/eDJp6Ry3
Nor more mRNA vaccines for respiratory viruses!
You here less about BionTech's mRNA colon cancer vaccine failure/discontinuation with poor outcomes. The media does not want to show case the unknowns and negativities associated with mRNA vaccines especially with viral season approaching. I have seen too much vaccine-induced autoimmunity or thrombosis in my days. mRNA covid shots will increase interferons about 280 fold which could be good if you have cancer. But a healthy taking it to protect against virus, you may have damage from the cytokine storm or miscarries but like Fauci, Murthy, and Walensky lets not tell the folks!!!! Vioxx got approved when I was a medical student. I'll never forget the tactics used to fool the people.
Perhaps you woke up in a cycle of unwarranted exuberant optimism.
1) The bespoke nature of the vaccine makes it personalized, which is both important, and also unlikely to be universally marketable (cost-efficient).
2) The biggest caveat is that this is melanoma-and extrapolation of findings from melanoma to epithelial malignancies is both unwarranted and injudicious.
3) As this moves forward in melanoma, one will find failures, because no limited biopsy will capture the full repertoire of bespoke antigens required for effective responses.
To my “amateur “ eyes, and compulsive nature, the stock price images are much more impressive due to the lack of a ZERO on the vertical axis? But that may be part of the churnalism?
I don’t think you should minimize the potential effect Sensible Medicine can have on longevity of the subscribers and their patients and friends!!
Thank you for your thoughts on the nature of sensationalist reaction to the Merck/Moderna announcement of positive topline results from the Phase 3 INTerpath-001 trial. Having worked half my career in academic research and the second half in pharma, I can tell you that the conclusions in the press release will indeed be confirmed. That is not to say that it is a good practice, but honestly, the companies are restricted from providing more detail if they plan to publish the results in a good peer-reviewed journal where the results will be trusted.
I will note also that the "results" come from a pre-specified interim analysis. When reporting clinical trial results, companies usually have a plan that includes publication at the time of database closure. Here, I suspect the trial team was truly surprised that the primary and some secondary endpoints were already met. That is why they didn't have a publication ready to go. Hopefully, they will be getting the publication out ASAP.
Companies also need to provide topline summary in order to comply with government regulations. They certainly don't want results known within the company to leak and put the companies at risk to insider trading and other ethical problems.
If you look at the trial record (NCT05933577) in clinicaltrials.gov, you will find that completion of the primary endpoint was expected in October 2029, over 3 years from now. The fact that the data were statistically significant now offers a dramatic clue that the published results are also dramatic. Furthermore, the record shows that the enrollment was over 1000 patients and the clinical characteristics of those patients are defined, though obviously not the demographics.
Just one more thought about safety - the Phase II trial results were just reported at ASCO this year. Yes, it is very important to know whether the Phase III confirms the risk/benefit picture.
The real problem here is Wall Streets' reducing clinical trials to binary pivots as your graphic shows. But in this case, they are probably right.
Thank you for the insider info! I’m still wondering how expensive made-to-order injectables are going to be!
To publicly traded companies, the stock price is everything. The press release was about money, not about medicine, and certainly not about improving patient care.
Shame on the mainstream media for noting it at all. In the old days of paper newspapers, it would have rated a column inch in the Business section. Maybe.
The stock trading done by algorithm-driven computers drove up the stock price of both companies in response to the press release, closely followed by retail investors chasing the next big thing.
Those of us who care about the treatment, and whether it makes a difference to melanoma patients will wait for the paper. And Sensible Medicine’s careful take on it.
“… a robust market to support it and therefore it does not the support of federal dollars.’ You left out the needed word ‘need’.
Great article - thanks.
Man, typos galore today. Fixed. Thanks.
Give the man some coffee!
Excellent article, Dr. Cifu. My brows did raise in wondering if public figures would be more likely to admit mistakes if they were not threatened for being wrong during very challenging times. And also thanks for the stock tips.
I think you missed your chance to buy!
Dr. Cifu: First, I love the catchy byline!
Second: this sentence from the opening paragraph is confusing me: “The combination therapy decreased recurrence-free survival and distant metastasis-free survival.”
The internet press release by the companies say:
“Patients given both treatments were less likely to have the cancer return or spread than those who received Keytruda alone, the pharmaceutical companies announced Wednesday.”
Should your sentence read “the combination therapy reduced recurrence and distant metastasis”, or “the combination therapy increased recurrence-free survival and distant metastasis-free survival” (increased the time of survival??)
Maybe because it’s 0500 I’m terribly confused and your terminology is completely correct.
Thanks for this post! The mRNA neoantigen therapy could be a great treatment—but as you said, we need to see the Phase 3 trial data in full! (Not yet released—do they have 70 years in which to do so? How expensive will this “made-to-order” injectable be????😬😬😬)
Fixed! Thanks.
I like your word choice: improved.
If you don’t mind, I have an eye for editing and could provide free feedback like this! Only if welcomed by you.
Give the man some coffee !