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A Glioblastoma Vaccine? Not Yet.

If you get your biomedical breaking news from the British press, you will have heard all about a very promising vaccine treatment for glioblastoma. (“Remarkably promising” – BBC. “Could add years” – The Guardian. And there’s the Daily Mail (naturally), The Independent, and more). That would be good news, because that’s a terrible diagnosis with very little in the way of effective treatment. But if you get your breaking biomedical news from the British press, then I am very sorry for you.

That’s because this is DCVax, from Northwest Biotherapeutics. And this vaccine has been twisting and turning through the clinic for ten years now, under circumstances more suited for a soap opera than for a biotech company. I’m not sure I can summarize it all – here are a couple of articles reprising the story as of last year, so start there. (If you’re a Stat Plus subscriber, go here). There have been financial troubles, allegations and investigations, clinical holds, claims and counterclaims – and through it all, the one constant has been the NWBO has never been able to explain to anyone quite what is going on. That even goes for questions like “Why did regulatory agencies put a hold on your trial?”, “Why haven’t you enrolled the number of patients you said you would?”, and “When will you have actual data to present?” Minor stuff. At one point, the company actually attempted to explain a delay by saying that members of its management team had the flu.

I last wrote about the company in 2014, during yet another bizarre development. That was when a Washington Post columnist went after Adam Feuerstein (then with TheStreet.com) for being part of a conspiracy of evil short-sellers trying to harm this innocent little company. A letter of apology was eventually produced, albeit a carefully worded and rather lawyerly one, and I would submit that the subsequent history of NWBO illustrates that no evil conspiracy has been required. They were delisted from the NASDAQ, for example, and have been trading as a penny stock.

At any rate, the company has now published some analysis of the interim data, but as that Stat Plus piece makes clear, this is not really a satisfactory way of handling things. The company itself says that it has not reached the number of overall-survival cases that it needs to declare the trial finished, so the data are supposed to still be completely blinded. Because of the trial’s crossover design (patients getting standard of care could later on receive DCvax if the glioblastoma recurred, which it almost always does), about 90% of the trial’s participants have ended up getting the vaccine. That sounds like it’s going to make the workup of the data rather complicated, and it could also make the actual comparison to standard of care tricky as well. The current paper doesn’t address these questions, because it can’t, other than to say that since the great majority of the patients got the vaccine anyway, hey, let’s just look at the still-blinded data and run with it.

They expect to hit their overall number later this summer, and at that point they’ll start working through the data. The company has already warned investors that this could take many months, so it’s anyone’s guess when we’ll see the actual results. No celebrations should take place until that occurs. The entire dendritic-cell-vaccine idea that the company is working on has been kicking around for at least twenty years now, with little success, and DCVax itself first entered the clinic in 2002. The company has also worked on a prostate cancer vaccine using the same methods, but although a Phase II trial completed about ten years ago, they have never been able to partner it with anyone to go into Phase III. Couple this with the extremely aggressive and constantly changing nature of glioblastoma itself, and it’s hard to be optimistic. Unless you read the British papers.

33 comments on “A Glioblastoma Vaccine? Not Yet.”

  1. Peter Kenny says:

    I read the ToryGraph (unless likely to be ‘caught short’ in a public lavatory in which case I favor smaller pages and lower information content of the Daily Fail) primarily to be entertained by the wisdom of Spitting Feathers In Chalfont St Giles in Letters to Editor.

  2. Bal says:

    Like the US media – or indeed any other media – is any better.

    1. anon says:

      US (and I’m sure any other) media fail in many ways, but it seems to me that the British press is particularly susceptible to wild stories about medical breakthroughs.

      1. ingodwetrust says:

        is it because US audience cares less about science?

        1. loupgarous says:

          To your question “is it because US audience cares less about science?”, I think Derek was pretty clear on the proximate answer – “British journalism is a little on the sensational side.”

          Which isn’t to say that US journalists don’t get a little carried away, but US laws on promotion of drugs prior to New Drug Approval, or for indications not FDA-approved are stricter, apparently, than they are overseas. The whole reason we HAVE a Food and Drug Administration in the US is because of the problem we had with promotion of drugs which were either ineffective for the diseases they were promoted for, or were toxic in ways that we now consider unacceptable. So FDA has, from the beginning, had a strong legislative mandate to crack down hard on unsupported claims of efficacy for drugs.

          Any tidal wave of press enthusiasm for an investigational drug with DCVax’s track record in clinical trials would probably cause a non-clinical investigation by the FDA, Federal Trade Commission and Securities and Exchange Commission to make sure nobody making claims for the drug’s efficacy stood to make money from a public perception that a cure for glioblastoma was in the immediate future and that, incidentally, the manufacturer’s penny stock might be a strong “buy” very soon.

          THAT is why DCVax isn’t a buzz word here in the States. There actually was a decent amount of coverage of odanacatib in the lay press before and after Merck cut its trial short for elevated risk of stroke in clinical trial patients.

  3. Barunuuk says:

    So not sue how to take this article. It has a negative spin to it, and even promotes and references Adam Feuerstein, but it provides no critical analysis nor basis to why DCVax will fail, and it completely ignores the positive overall data that was just published. The fact that the mOS of the overall population is 23.1 months and that was taken a year ago, when 1/3 of the patients had yet to have reached 27 months from randomization, meaning that mOS has increased since then (unless all 1/3 of the patients did not make it past 23.1 months.). Wow! Talk about ignoring the facts.

    1. David E. Young, MD says:

      As a practicing oncologist, I have been rather disappointed in a similar treatment, Provenge. I have never treated any prostate cancer patients (way too expensive) but my partners have and for the most part, they were underwhelmed with how Provenge worked. One of the problems, is that Provenge is FDA approved for prostate cancer where there is imaging findings of metastatic disease. These drugs may work better when given earlier, when there is just a continued rise in PSA but no metastatic disease that an be imaged…. but it is not FDA approved for that. Northwest Biotherapeutics has been struggling. Perhaps their treatment would be better applied to earlier disease… that might mean “less impressive” results and yet more important, if it delays the onset of imaging metastatic disease for a year or better. The price would have to come down.. because who would spend 90,000 dollars if they just have a rising PSA? With these very, very high costs, the idea of putting this sort of treatment into practice is full of trouble. Good luck though.

  4. John Wayne says:

    When a company in the clinic has trouble getting their clinical trial work done, and they are cagey about the data, there are three main reasons that explain 99% of the observed cases:

    1. Incompetence
    2. Slow rolling so that key investors can make their exits
    3. Both 1 and 2

    This one is especially weird because I would think that enrolling patients would be straightforward. Maybe I’m wrong here, but terrible outcomes from the current standards of care ought to lead to people banging on the doors to get in.

    Like everybody else I hope this thing works; it would be the best possible outcome for everybody.

  5. anon says:

    Well, at least it wasn’t a “we met our endpoints, but you’ll have to take our word for it because Adam Feuerstein broke into our office, transformed into a werewolf, and ate our clinical data” announcement.

  6. As a Brit, I often despair at the quality of science, medicine and health-related reporting, both online and in the deadwood press, but as a journalist or editor, why strain yourself to feed an uncritical audience?

    And for anyone who relishes a good story, I recommend a dig into Northwest’s history – fraud allegations, related party transfers, a rogue analyst (and Northwest director) who, funnily enough, liked to write enthusiastically about the company, a high-profile fund manager with a bruised and battered reputation, the ex-FBI agent tasked with discovering WTF was actually going on…..Wonder if anyone owns the film rights?

  7. ChairmanMao says:

    British Fake News- thanks for wasting our time.

    Now when I see a scientific manuscript or report from the UK I wince then move on.

    1. Disgusted of Tunbridge Wells says:

      To my knowledge this unreliability does not extend to scientific manuscripts hailing from Albion, only the reports of the lay press.

  8. David Edwards says:

    This is why I wait for something of substance to appear in Nature, Science, PNAS or Proc. R. Soc. Lond. B. on such matters.

    The Daily Heil (a quick peek at its history around the 1930s, along with that of the owner thereof at that time, will tell you why I call it this) has, shall we say, an interesting approach to scientific journalism. A disturbingly large percentage of its regular readership consists of people whose age is now determined by carbon dating, who maintain fond fantasies about a Golden Age that never was, and when speaking in private, think that all their problems will be solved via the simple expedient of “Get Rid Of The Bleeding DarkiesTM”. In short, closet (or sometimes, openly declared) fascists shitting themselves at the looming presence of their own mortality. Which is why lots of column inches within this burst haemorrhoid of a publication, are devoted to gerontological matters. The people at the top of the paper are staring a demographic time bomb hard in the face, one that will see their readership immolated in the flames of millennial resentment over the banking crisis, economic “austerity” for everyone but the rich paymasters of right-wing political parties, and the general torching of decent, civil society by the Parasite Papers brigade. That part of the output of this venomous rag not devoted to dog-whistle racism, is aimed at trying to persuade the Palaeolithic section of its readership to cling on and not die yet, because once they’re gone, even such measures as registering the company in Bermuda to dodge paying tax in the UK won’t save it from extinction. Devoting column inches to upbeat messages about Alzheimer’s, age related cancers, etc., is part of a desperate plea to its shrinking base not to head for that dinner date with Mr G. Reaper just yet. Less extreme versions of the same phenomenon affect the Torygraph and Dirty Desmond’s Express, the latter characterised by a particularly rectally self-inserted readership, many members of which would blow arteries on a grand scale if they knew about the owner’s large portfolio of hardcore pornography distributors. Especially the parts of that portfolio devoted to various stereotypical fantasies about the Smelly Brown Foreign PeopleTM so loathed by the usual consumer of right-wing dreck of the ilk being covered here.

    Moving back to the actual science, I for one wish to know just how one is supposed to ‘vaccinate’ against a moving target exhibiting the slipperiness of glioblastoma. Does DCVax involve any of the developments in VSV I’ve been reading about in actual scientific journals, or is it something completely different? Only VSV has been under the microscope for some time, and I’ve not yet encountered even moves to Phase I with this. VSV, being a virus, can of course evolve in tandem with its target, though ensuring said evolution doesn’t unleash a new pathogen you don’t want is the tricky part, a problem that’s been hovering over HIV vaccine research for a long time. Even so, having seen some actual peer reviewed literature on VSV, that’s the route I’d choose if I was desperate enough – volunteer to be a guinea pig for a VSV trial.

    1. DrConcerned says:

      Are you feeling Ok?

      1. John Dallman says:

        I think he’s OK. British understatement can be confusing.

    2. pete says:

      @ David Edwards
      Your 2nd paragraph took the prize among my morning readings. One slight point of refinement: I believe it’s Mr. G. Reaper, Esq.. Ya’know, lawyers…

  9. Dr. James pompous iii, i have my own lab now says:

    And…..elizabeth holmes. well its not exactly about the British press is it? Its more about pharma penchant for profit using disinformation. You people just need to get over yourselves and admit you will do anything for a buck and a vacation to Hawaii. Enjoy it.

  10. The right and just Dr. Bon Swine the Ignorant, first class says:

    The elon musk fallacy: anything that goes wrong for your technology is the press’ fault.

  11. Daily Male says:

    I actually quite like the Daily Mail. Their well written journalistic pieces highlight important stories to every day people that the bigger media outlets are to nervous to cover, or try to cover up.

    1. Skeptical says:

      I’m not even British, but that made me laugh.

  12. johnnyboy says:

    I live in the UK, and heard that story on BBC 4 radio news (the ‘serious’ BBC channel). Working as I do in cancer research, I listened with some interest. The story was all about ‘new hope for brain cancer patients, could add years to life’, etc.etc… complete with grateful survivor testimonies. When they said in the last sentence that this was DCVax, my jaw dropped. Nowhere in the story was it mentioned that this was an interim report with treatment still blinded, ie. that no actual conclusion could be drawn at this stage. No mention either of the fraught history of this drug and the near-fraudulent behavior of its CEO, milking every investor dollar she can and using the company as her personal piggy-bank, while giving false hope to vulnerable patients. I’m used to the crap that passes for medical reporting in the UK, but this was miles below rock bottom. Even made a complaint to the BBC about it (complaining to the BBC is a national hobby here, they even make a weekly radio show about the complaints they receive).

  13. Sulphonamide says:

    Can anyone from e.g. Germany or France comment on whether their press also has this inexplicable penchant for repeatedly reporting scientific failure as ground-breaking success (see the endless stream of beginning-of-the-end for Alzheimer’s)? I fear we may indeed be at the very bottom of the trough for lazy / clueless scientific journalism.

    1. wei says:

      I read the french press, mostly Le Monde (Guardian-lite), occasionally Liberation (left) or Le Figaro (right). I don’t remember seeing such sensationalist reporting about “science” very often I’d say science rarely makes the headlines, unless it’s about climate or food.
      Big stories tend to be about surgical reconstruction (eg faces, or more recently bronchi/trachea), lots of flag-waving especially for surgeons.

  14. David Powell says:

    The NHS have a great blog called “Behind the Headlines” that looks at health-related headlines, and gives some background and puts them into perspective.

    http://www.nhs.uk/news/Pages/NewsArticles.aspx

  15. Obvious snark says:

    Since the right-to-try bill has been signed into law, does that mean that this treatment can now be offered to patients ‘at cost’ since a clinical trial is ongoing? That oughta be fun.

    Seriously though, has anyone thought about the implications of using a vaccine in this way? Who would want to trade cancer for autism???

    1. Thanks- that made me laugh.
      Not that the anti-vacineers will be concerned since all of that aluminium foil wrapped around their heads also keeps out cancer rays.

    2. Skeptical says:

      If you’re implying that any vaccine, solely by virtue of being a vaccine, might cause autism when given to a (generally elderly) cancer patient, you’ve been reading some highly unreliable sources.

      It is possible in principle that some vaccines might cause autism. In practice, this has been thoroughly debunked AFAIK. But it is scientifically absurd to claim that all vaccines could have such a specific effect. If our immune systems were that predisposed to wreak havoc in our bodies, we’d all be autistic or dead already.

  16. Robert says:

    Well, the interim info also was reviewed by a peer review journal, so it is not merely the british media that is reporting on the interim data. And, the press in the USA is also reporting on this …. so do you distrust all media and press from every country in the world?
    This is where the interim report of the blinded data was reported:
    https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6
    Sure, the info is still blinded, but also “appears to be encouraging”: Median survival of top 100 patients is 40.5 months, Median survival of all 331 patients is 23.1 months, Longest survivors have exceeded 7 years. Whereas, the standard treatment is surgery followed by radiotherapy and chemotherapy. Patients who receive this standard care live for 15-17 months on average.

  17. Ais says:

    I think the reason this received so much publicity in the UK press was because it had a “peg” in the form of the recent death of a well-known former government minister from the same disease .

    I also notice that the Guardian piece was lifted from Press Association, rather than written by its excellent Health Editor Sarah Boseley. She was probably on holiday and the paper panicked when they saw everyone else covering it.

  18. Brian Rockell says:

    I am a GBM patient in the UK. I tire of stories in the media heralding magic cures about to be available. In all the excitement of new possibilities there was no mention of the cost and for the publically funded National Health Service the huge cost make it an unlikely standard treatment even if the results are proven

    1. D says:

      Well written, and agreed with. Thank you, as I too am a GBM patient.

  19. D says:

    While I, as a Glioblastoma sufferer, can appreciate people’s approach to this potentially being a fair statement against various newspapers and even Northern I do not find the lack of anything positive ever against this disease from you, Mr. Lowe, a benefit. My assumption is that you feel that you, Mr. Derek Lowe, assume that you should be listened to for you support of friends only, or perhaps those that pay you? The fact that you wrote not one area of positive hope here to actually be useful just brings home that as a writer you are no better as an individual than how you describe the newspapers and Northern…How very disappointing you are.

  20. LRK says:

    My 67 year old husband is a 5 year survivor of glioblastoma with no grow back indicated in any of his latest MRI’s, whatsoever. He completed the DCVax trial with no ill side effects. I would highly recommend it to all who can get it.

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