Tuesday 29 May 2018

DCVax Update


https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6

Mike B

9 comments:

  1. anyone know how to get it? I am from Isarel!

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    1. The only place I know of where you could get this outside of a trial is in the United Kingdom (UK Specials Program). Apparently there is a long waiting list.

      Prices as of late 2015 were 53,000 Euros for manufacture of the vaccine and release of the first three doses. An additional 17,000 Euros for each subsequent dose. This doesn't include the cost of leukapheresis to harvest white blood cells (several thousand US dollars). A 20% VAT tax is also charged in the UK on each dose. This tax amounted to 10,600 Euros for the first three doses (2015 prices).

      Also you would need about 2 grams of fresh or properly frozen tumor tissue.

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    2. Total costs by the end of it could be well over $100,000.

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    3. Hello Mr. Nimrod Raz,

      We , at Millennium Cancer Center , Delhi NCR , are performing dendritic cell therapy at our center. We would be happy to help you in this regard. The cost for first six doses of the vaccine is 20,000$.
      For further information please contact undersigned .

      Nidhi Lamba
      9821488310
      info@gssmcc.com
      Millennium Cancer Center
      Gurgaon , Haryana
      India
      http://www.millenniumcancercenter.com/

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  2. You beat me to it Mike, I was just about to post on this.

    Some things to keep in mind: the results are presented for the entire trial cohort, prior to unblinding, so results aren't separated into those who got DCVax upfront and those who got placebo upfront. Because of this, only overall survival results are presented, and not progression-free survival. Complete results will be presented in a later publication after unblinding.

    These results can't really be compared to any other phase 3 trial for newly diagnosed glioblastoma, because all patients in the trial had total or partial resection, while most other trials include some patients with biopsy only. The closest comparison would be with the phase 3 rindopepimut trial, but that trial only included those positive for EGFRvIII. The randomized phase 2 ICT-107 trial could be used for comparison, but the full results of that trial were never published. Still, these unblinded results for the total DCVax trial cohort are slightly better than the preliminary data presented in press releases for ICT-107, and about 8 months better than the control (placebo) arm of the ICT-107 trial for the MGMT-methylated subgroup, and also about 5 months better than the control arm of ICT-107, MGMT unmethylated subgroup.

    To compare the DCVax trial (survival from surgery) and ICT-107 (survival from randomization), I had to add 2.7 months onto the ICT-107 results (2.7 months median between diagnosis and randomization).

    I'll also have a look at these results in comparison to the phase 3 rindopepimut ACT IV trial (placebo and experimental arms).

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    1. Comparing with the ACT IV rindopepimut trial, median overall survival in the total DCVax cohort is about 3 months better than either arm of the rindopepimut trial (23.1 months from surgery in DCVax versus 20.2 - 20.3 months from diagnosis in ACT IV).

      Comparing the Gross Total Resection subset of the DCVax trial with the Minimum Residual Disease subset of the rindopepimut trial, median survival from surgery/diagnosis is several months better in DCVax trial (25.4 months versus ~23 months in rindopepimut).

      But small improvements in median overall survival realistically means that the vaccine probably didn't work at all in some, but probably worked extremely well in others. The real interesting data to watch for will be percentage surviving at 4 and 5 years and beyond - the long tail of longer term survivors.

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  3. For those of you who belong to Musella's Brain Tumor Treatments yahoo group, we're discussing over there as well.

    https://groups.yahoo.com/neo/groups/BrainTumor-Treatments/conversations/topics/92107

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  4. Al Musella brought up an important point on the yahoo group discussion: the very long median survival (>7 years) in the subgroup of patients that had survived to at least 3 years, in the preliminary results of the DCVax trial. In response to that I wrote:

    "If 24.2% of the 182 patients (living or dead) who were at least 3 years from first surgery survived to 3 years, and of that 24.2% the median survival was 88.2 months (7.35 years), this implies that about 12% of the 182 patients survived to 7.35 years or more (because 12% is half of 24.2%), at least by Kaplan-Meier estimates. A big caveat is that many of the patients could have been censored for lack of follow-up before that 7 year mark, so we'll need to wait for mature data to confirm all of this.

    The best 5 year overall survival data I've seen was in EF-14 - for the patients randomized to Optune, 5-year survival rate was 13%. For DCVax if the preliminary Kaplan-Meier estimates are anywhere close to the mature final data, we could be looking at 7 year survival rate of over 10%, and this is including those randomized to placebo, who mostly didn't get DCVax until recurrence."

    Looking at median survival statistics can be deceiving unless you also look at the the long tail of long-term survivors. The number of 7 year + survivors with DCVax may be more than any previous trial for GBM.

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  5. This is a pretty nice DCVax write-up (though from a conflicted source due to author's association with a hedge fund which is invested in the biotech company owning DCVax, so also to be read as such):

    http://static1.1.sqspcdn.com/static/f/428566/28026405/1542231723430/NWBO+-+White+Paper+Rago_48081593.pdf?token=rR5pmAu4TehqLK0U%2BLSPRCSSEGw%3D

    By the way, the DCVax trial seems to be about to get un-blinded very soon now, hopefully with strong results.

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