[HN Gopher] Breakthrough drug trial saw cancer vanish in every p...
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       Breakthrough drug trial saw cancer vanish in every patient (2022)
        
       Author : wjb3
       Score  : 98 points
       Date   : 2024-04-05 19:27 UTC (3 hours ago)
        
 (HTM) web link (www.euronews.com)
 (TXT) w3m dump (www.euronews.com)
        
       | qclibre22 wrote:
       | 2023 news: original paper :
       | https://www.nejm.org/doi/pdf/10.1056/NEJMoa2201445
        
       | dekhn wrote:
       | I don't think this is the first study where 12 patients showed
       | full remission. Further, you'd expect that to happen _by chance_
       | at the scale that we run small trials like this.
        
         | marginalia_nu wrote:
         | Flipping 12 coins and having them all land on heads is a 0.02%
         | probability event. Cancer spontaneously going into remission in
         | a patient is pretty far away from a coinflip.
        
           | dekhn wrote:
           | That's true but this is a clinical trial where the patients
           | are being treated- the patients were selected according to
           | strict criteria, and received other treatments in cancer
           | centers. It's not really just "coinflips", it's heavily
           | biased coinflips.
           | 
           | Maybe I should have put this in a more productive way: I
           | prefer studies that have a large enough n that you can
           | actually measure the failure rate. There's a classic
           | statistics paper where an operation was done on 3 patients
           | and none died- the paper's title is "If nobody dies, is
           | everything OK?" and goes into whether you can reliably
           | conclude causal effects with very small n.
           | 
           | Further- let's say the drug caused remission in 50% of the
           | patients, and the other 50% had spontaneous remission (or
           | remissionc aused by other aspects of the treatment). Now it's
           | not 1/2 * 12, it's 1/2 * 6 (or whatever base probability you
           | want to choose). If you compare that probability to the
           | number of people in clinical trials in the US, you would
           | expect that after 30-40 years, you'd see at least one trial
           | with 12 patients with complete remission.
           | 
           | (I don't actually doubt the drug is effective. We already
           | know that. And we already know that studies this small really
           | stretch the concepts of significance and causality).
        
             | superb_dev wrote:
             | I think most people would prefer a study with more
             | participants, but you can't jump to a large human trial
             | right away
        
               | dekhn wrote:
               | Patient recruitment is hard, but this is a phase II on an
               | already approved drug. Typical Phase II has at least 100
               | patients.
        
           | readthenotes1 wrote:
           | As other people have mentioned, this is just a variation on a
           | theme of other successful drugs. It may well be that the odds
           | are greater than 50% the way they selected the patients.
           | 
           | There's also publication and hacker News front page bias to
           | consider in the odds making as well...
        
             | dekhn wrote:
             | I end up seeing a lot of these discussions and you can
             | always tell the difference between a person who doesn't
             | know much math but works in the field, to somebody who
             | knows a lot of math but doesn't work in the field.
             | Experience and wisdom matter a lot wrt drug discovery and
             | cancer treatment.
        
           | bawolff wrote:
           | > Flipping 12 coins and having them all land on heads is a
           | 0.02% probability event. Cancer spontaneously going into
           | remission in a patient is pretty far away from a coinflip.
           | 
           | You don't actually have to run that many trials before a
           | 0.02% liklihood event happens by chance.
        
             | pie420 wrote:
             | only 5000 or so trials, easy
        
       | Kalanos wrote:
       | It's a checkpoint inhibitor. Those have been used for ~ every
       | cancer type for over a decade. Keytruda has been a top-selling
       | drug for years.
       | 
       | It looks like this trial was neoadjuvant (before treatment/
       | alternative to chemo and surgery), but that's not new either.
       | 
       | immunotherapy typically has much lower _response rates_ though,
       | so maybe it 's the mismatch repair selection strategy that's
       | novel
       | 
       | at a sample size of 12... they could have gotten lucky
        
         | kjkjadksj wrote:
         | Using mismatch repair has been a concept for almost a decade
         | now, the initial pd-l1 papers were very much focused on it.
         | 
         | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5576142/
        
           | Kalanos wrote:
           | thanks. yeah i dunno then
           | 
           | First-line nivolumab metastatic colorectal w MMR:
           | https://pubmed.ncbi.nlm.nih.gov/34637336/
           | 
           | first-line keytruda metastatic colorectal w MMR:
           | https://www.nejm.org/doi/full/10.1056/NEJMoa2017699
        
         | tyingq wrote:
         | I'm no expert, but it says it's Dostarlimab, which is billed as
         | a monoclonal antibody. Some googling suggests that monoclonal
         | antibodies and checkpoint inhibitors are both immunotherapy
         | approaches, but that they aren't the same.
        
           | mcbain wrote:
           | They are
           | https://en.m.wikipedia.org/wiki/PD-1_and_PD-L1_inhibitors
           | 
           | The hint is the -mab naming.
        
             | pfdietz wrote:
             | -ab means it's an antibody. There are many kinds of
             | antibodies, not just to those two proteins.
        
               | semi-extrinsic wrote:
               | And -mab means monoclonal antibody. But your point still
               | stands, there is a huge number of -mab drugs out there
               | today.
        
               | pfdietz wrote:
               | It's a really great technology, and not just for drugs.
               | It deservedly won the Nobel Prize in Medicine in 1984.
        
           | Kalanos wrote:
           | checkpoint inhibitors are antibodies
        
           | hentrep wrote:
           | For reference, dostarlimab (JEMPERLI) is essentially GSK's
           | answer to Merck's pembrolizumab and BMS's nivolumab. Or
           | KEYTRUDA and OPDIVO, respectively, if you're in the USA and
           | bombarded with pharma ads. All three are monoclonal
           | antibodies that block PD-1 on T cells, thereby stimulating
           | the body's immune system.
        
             | Kalanos wrote:
             | i wouldn't refer to it an an immunostimulant. it prevents
             | tumors from hiding.
        
         | adamredwoods wrote:
         | The bigger question I have, if these PD-1 blockers all have the
         | same method-of-action, why are they showing different results
         | for different tumors?
        
       | vikramkr wrote:
       | For context, this study was in 2022, this drug had received
       | accelerated approval in 2021 and was fully approved by the FDA in
       | 2023 for mismatch repair deficient endometrial cancer.
       | (https://www.fda.gov/drugs/resources-information-approved-
       | dru...).
       | 
       | It's awesome to see the amount of progress in cancer that deeper
       | understanding of the disease is bringing. Identifying
       | interventions that work in a subset of patients with specific
       | mutations, targeting them specifically, using immunotherapies,
       | all incredibly cool and impactful.
        
         | ip26 wrote:
         | Success with targeted therapy also hopefully paves the way
         | towards the understanding we need for generalized solutions.
        
       | davikr wrote:
       | I am so excited for the monoclonal antibody revolution of
       | Medicine. Here's to them getting cheaper someday.
        
         | namibj wrote:
         | How expensive are they to make these days? There's also one in
         | progress made from human stem cells that blocks a teeth-
         | regrowth-inhibitor, causing mice and ferrets to grow more and
         | new teeth.
         | 
         | It should allow human adults to grow new teeth over a period of
         | 2~5 years, if removal of the old teeth is surgically assisted
         | (the roots are too deep to have it work automatically, thus
         | evolution of the blocker). Oh, and it's systemic as I
         | understand, so usage would involve pulling all the teeth
         | present when starting.
        
           | Terr_ wrote:
           | > There's also one in progress made from human stem cells
           | that blocks a teeth-regrowth-inhibitor, causing mice and
           | ferrets to grow more and new teeth.
           | 
           | That's quite an unexpected mix of optimistic, cute, and then
           | disturbing right there.
           | 
           | > Oh, and it's systemic as I understand, so usage would
           | involve pulling all the teeth present when starting.
           | 
           | Never mind, fully disturbing now. :P Though I suppose it
           | might be interesting for folks who've already lost almost all
           | of them...
        
           | mikeInAlaska wrote:
           | > How expensive are they to make these days?
           | 
           | A good question, I can't answer. But I can tell you, when my
           | daughter had her liver transplant, they gave her an insane
           | amount of medications for weeks. They only gave her one shot
           | of a monoclonal antibody "Basiliximab". The syringe with it
           | was escorted by two guards from the pharmacy.
        
             | knodi123 wrote:
             | > The syringe with it was escorted by two guards from the
             | pharmacy.
             | 
             | Isn't it only, like, a few thousand dollars? By all means,
             | be careful with it, but you don't see teams of guards at
             | the apple store escorting hardware to the customer.
             | 
             | Was this maybe earlier in development and the price was
             | much higher or something?
        
           | semi-extrinsic wrote:
           | A few years ago the pharmacy accidentally keyed in the full
           | price for two months (four injectors) of Humira, IIRC it was
           | like $3k. This is in Northern Europe, probably it's more
           | expensive in the US? Also I don't know if the price has come
           | down since.
           | 
           | Of course it's also a price vs volume thing, but I heard a
           | while back that scaling up bioreactors is the limiting factor
           | for these monoclonal antibodies.
        
         | Terr_ wrote:
         | As long as we don't get the cyberpunk dystopian outcomes like
         | tailored molecules dumped in the water supply to assassinate a
         | specific individual.
         | 
         | > They sent a slamhound on Turner's trail in New Delhi, slotted
         | it to his pheromones and the color of his hair. It caught up
         | with him on a street called Chandni Chauk and came scrambling
         | for his rented BMW through a forest of bare brown legs and
         | pedicab tires. Its core was a kilogram of recrystallized
         | hexogene and flaked TNT.
         | 
         | -- _Count Zero_ , by William Gibson
        
       | methodical wrote:
       | Original HN post on this same subject from 2022:
       | https://news.ycombinator.com/item?id=31630679
        
         | dang wrote:
         | Thanks! Macroexpanded:
         | 
         |  _A cancer trial's unexpected result: Remission in every
         | patient_ - https://news.ycombinator.com/item?id=31630679 - June
         | 2022 (232 comments)
        
       | aurizon wrote:
       | Are we going to see colo-rectal surgeons on the endangered
       | species list, not to speak of other cancer specialties?
       | 
       | https://www.youtube.com/watch?v=W2gABYTmXos
        
         | methodical wrote:
         | I mean there are more maladies that affect the colon and rectum
         | than just colon cancer, so I expect colo-rectal surgeons will
         | survive, if with a decline in positions.
        
           | aurizon wrote:
           | True, mechanical problems will endure, even if cancer is
           | defeated.
        
         | hentrep wrote:
         | This is actually one of the goals in colorectal cancer - organ-
         | sparing treatment options. In particular, using immunotherapies
         | in the neoadjuvant, peri-operative setting has shown tremendous
         | benefit in colorectal cancers. Work done by Myriam Chalabi
         | (Netherlands Cancer Institute) with the NICHE-1 study [0] and
         | Pashtoon Kasi (Cornell) with the NEST-1 study [1] have had
         | tremendous impacts for the up to 15% of patients who have
         | mismatch repair deficient CRC.
         | 
         | [0] https://ascopost.com/issues/october-25-2022/unprecedented-
         | wa... [1]
         | https://www.nyp.org/advances/article/gastroenterology/ongoin...
        
         | semi-extrinsic wrote:
         | From what I've heard, surgery to treat hand osteoarthritis is a
         | dying sub-specialty because the drugs are so effective now (and
         | the surgery has never been a very good solution).
        
       | sniperjoe360 wrote:
       | Really impressive results. The real victory here wasn't the
       | breakthrough drug, which many have pointed out is another flavor
       | of PD-1 inhibition (Nivolumab, Pembro) It's the patient selection
       | - careful curation of MSI status with Next Gen Sequencing.
       | Clinically it has already been implemented and is changing the
       | outcomes of thousands of patients every year.
        
       | xk_id wrote:
       | * in a 5-10% subset, of a subset, of a subset of cancers.
        
         | hentrep wrote:
         | At risk of taking the bait with this flippant comment, I'd like
         | to highlight your critique of what others used to long for as
         | "targeted therapy" or "personalized medicine". I suppose we
         | could always step backward to a world dominated by systemic
         | cytotoxic chemo, though. Which, to be fair, still has its
         | place.
         | 
         | Cancer tends to evolve at a rate that outpaces treatment
         | innovation, and the molecular determinants can be wildly
         | heterogenous. For example, a lung cancer patient can have half
         | a dozen tumors that all harbor independent oncogenic drivers.
         | It is not uncommon for a patient to undergo treatment with a
         | target therapy and see complete tumor responses in some
         | lesions, while others grow unimpeded.
         | 
         | We did not develop our own code base. Humans are a black box
         | and drug development is HARD.
        
           | xk_id wrote:
           | It's not a comment on the value of the treatment, the
           | headline is just wrong. Saying "cancer vanished in every
           | patient" without further qualification is ambiguous, not too
           | different from saying "illness was cured in everyone". The
           | correct title should have been "Success using a targeted
           | anti-cancer therapy".
           | 
           | Btw, there is still research that tries to find a general
           | mechanism for interventions. The other day I looked at
           | interesting work that hinged the delivery of disruptive
           | payload on telomerase activity. Telomerase is expressed
           | almost universally in cancer cells and in stem cells;
           | therefore somatic cells would be spared, and it's hoped that
           | stem cells would be able to recover.
           | 
           | Anyway like you said, both approaches are meaningful, which
           | is why it's important to tell them apart.
        
       | ChrisArchitect wrote:
       | (2022)
        
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