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Inomed Neurocare@InomedNeurocare
Great few days catching up with #neurosurgeons across the #UK at the #BNOS2022 in #Liverpool. Very interesting talks and a fabulous dinner! See you next time ??
#inomed #inomedneurocareltd
Please join us in congratulating Dr. Liau on her JEDI Trailblazer Award.
Linda M. Liau, MD, PhD, MBA
Chair of the Department of Neurosurgery
This prestigious award, co-sponsored by UCLA AAPI Faculty Alliance and DGSOM Justice, Equity, Diversity, and Inclusion Office, is given to faculty member who embodies leadership and excellence in advancing ideals of justice, equity, diversity, and inclusion.
Please RSVP here, and let’s celebrate her achievement on Friday, June 24, 5-6:30 pm.
Many diseases, one answer?
https://www.science.org/cms/asset/bc2a06ab-6342-41fc-96a4-bdc3a31bbaa8/productads.pdf
Two decades ago, no one thought immunotherapies would become mainstream in cancer treatment,” says Linda Liau, professor and chair of the Department of Neurosurgery at the University of California, Los Angeles (UCLA). “But now we are seeing the potential to cure cancers that were incurable. There will be a huge growth in cancer immunotherapy in the future.”
Immunology principles lie at the heart of medicine and have a much broader
impact than any other subspeciality within medicine, says Liau. But we still don’t know enough, she emphasizes. “The more we learn about human immunology, the better we can strive to cure incurable diseases.”
Looks like the coffee break was great!
https://mobile.twitter.com/YorkshireBTC/status/1539981458433097730/photo/1
I find it very interesting that a few of his tweets were taken down and the one of him doubting approval by NICE was also taken down. Hmmmm….
Linda Powers :7 th row.
Roger Stupp: 6 th row.
please post the STUPP presentation , plus slides. Is there a financial disclosures slide?
Don't know who he is, but the Benjamin Sanderson twitter box posting many serious questions and doubts.
Benjamin Sanderson@Benji_Sanderson
The end of another thoroughly intriguing day. Highlight had to be the #DCVax presentation. Very exciting. Now, time to get my ceilidh on! #BNOS2022
@BNOSofficial
The end of another thoroughly intriguing day. Highlight had to be the #DCVax presentation. Very exciting. Now, time to get my ceilidh on! #BNOS2022 @BNOSofficial pic.twitter.com/gPIoNDYE3s
— Benjamin Sanderson (@Benji_Sanderson) June 23, 2022
Thanks!
Pietro Ivo D'Urso MD FRCS@pidurso
#BNOS2022 if anyone can, Ash…Kan! Fantastic presentation of Prof Ashkan: exciting results from the Phase 3 trial of #DCVax-L in Glioblastoma
@BNOSofficial@KingsNeuro
#BNOS2022 if anyone can, Ash…Kan! Fantastic presentation of Prof Ashkan: exciting results from the Phase 3 trial of #DCVax-L in Glioblastoma @BNOSofficial @KingsNeuro pic.twitter.com/xDpZBYnZa1
— Pietro Ivo D'Urso MD FRCS (@pidurso) June 23, 2022
Sally Price@saspist
Prof Ashkan @KingsNeuro presenting promising results for DCVax for GBM with 2.8mo OS improvement, marked change in long term survival. Also slide showing predictors for good outocome. #bnos2022
Prof Ashkan @KingsNeuro presenting promising results for DCVax for GBM with 2.8mo OS improvement, marked change in long term survival. Also slide showing predictors for good outocome. #bnos2022 pic.twitter.com/RPrO2sUV06
— Sally Price (@saspist) June 23, 2022
Benjamin Sanderson@Benji_Sanderson
RECURRENT GBM!! #DCVax #BNOS2022
@BNOSofficial@NorthwestBio
Benjamin Sanderson@Benji_Sanderson
DCVax in GBM. An extremely exciting novel area with VERY encouraging results.
@NorthwestBio #BNOS2022 @BNOSofficial@
Benjamin Sanderson@Benji_Sanderson
Oooooo, hello you. #BNOS2022 @NorthwestBio #braintumournorthwest
Oooooo, hello you. #BNOS2022 @NorthwestBio #braintumournorthwest pic.twitter.com/Hl1alIE0gl
— Benjamin Sanderson (@Benji_Sanderson) June 23, 2022
Benjamin Sanderson@Benji_Sanderson
Even a benefit in patients with significant residuum! #BNOS2022
Benjamin Sanderson@Benji_Sanderson
External controls to circumvent this problem. Elegant but I fear this will cast significant doubt and shadow over what may be a truly fantastic development in treatment of GBM. Feelings reminiscent of EF-14 trial. #BNOS2022@BNOSofficial
External controls to circumvent this problem. Elegant but I fear this will cast significant doubt and shadow over what may be a truly fantastic development in treatment of GBM. Feelings reminiscent of EF-14 trial. #BNOS2022 @BNOSofficial pic.twitter.com/KCHsUbA1zA
— Benjamin Sanderson (@Benji_Sanderson) June 23, 2022
HCEngagement@EngagementHc
#BNOS2022 Listening to The Prof talking about Autlogous Tumour Lysate-Loaded Dendritic Cell Vaccination for Glioblastoma trial data
@KingsNeuroLab@KingsNeuro@BrainTumourOrg
#BNOS2022 Listening to The Prof talking about Autlogous Tumour Lysate-Loaded Dendritic Cell Vaccination for Glioblastoma trial data @KingsNeuroLab @KingsNeuro @BrainTumourOrg https://t.co/1NOSwKGH3K pic.twitter.com/Y1cSbeuD3i
— HCEngagement (@EngagementHc) June 23, 2022
Shaveta Mehta@shaveta_mehta
Prof Ashkan sharing the results of Phase 3 trial of DCVax in GBM #BNOS2022 @BNOSofficial
Prof Ashkan sharing the results of Phase 3 trial of DCVax in GBM #BNOS2022 @BNOSofficial pic.twitter.com/iyEh5aL12R
— Shaveta Mehta (@shaveta_mehta) June 23, 2022
I agree.
Top Scoring Oral (20 mins)
Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination in Patients with Newly Diagnosed and Re current Glioblastoma: Survival Results from a Phase 3 Trial
Mr. Keyoumars Ashkan, Prof. Dr. Linda M. Liau, Dr. Marnix L. Bosch
IDHwt glioblastomas show opposing resistance mechanisms across patients in response to standard treatment
Dr. Georgette Tanner, Dr. Martina A Finetti, Dr. Steven Pollock, Dr. Nora Rippaus, Dr. Alexander-Francisco Bruns, Ms. Catherine Hogg, Dr. Alastair Droop, Dr. Anke Bruning-Richardson, Dr. Mathew Care, Mr. Joseph Wilkinson, Prof. Michael Jenkinson, Mr. Andrew Brodbelt, Dr. Aruna Chakrabarty, Dr. Azzam Ismail, Prof.
Susan Short, Dr. Lucy Stead
Pro-drug nanoparticle loaded supramolecular hydrogels for drug delivery to IDH1 wild-type glioblastoma
Dr. Robert Cavanagh, Mr. Saif Baquain, Prof. Cameron Alexander, Prof. Oren Scherman, Dr. Ruman Rahman
Where do people with primary malignant brain tumours die? A national cohort study inEngland, using GlioCova data
Dr. Micah Caldano, Dr. Joanne Droney, Ms. Radvile Mauricaite, Ms. Kerlann Le Calvez, Dr. Matt Williams
2021 Advent Bioservices payment information for ADCV.
Cost for manufacturing 6 doses ( induction phase and booster phase) for 1 year of treatment: £150 000
Cost for ongoing (twice per year) maintenance doses: each semi-annual maintenance dose= £25.000
$NWBO looks like Advent is getting ready to ramp up production at Sawton pic.twitter.com/pqpjVZnVLr
— TiltMyBrain (@TiltMyBrain) April 16, 2021
The 2022 Rocky Mountain Neurosurgical Society Annual Meeting.
"The invited guests will be Linda Liau, Md, PhD"
2022 – 57th Annual Meeting – Coeur d’Alene,
June 18 – 22, 2022
https://rmns.org/2022-55th-annual-meeting-coeurdalene/
BetIsOn,
You can celebrate Linda Liau’s achievement on Friday, June 24.
You can attend in person or via Zoom. https://uclahs.az1.qualtrics.com/jfe/form/SV_74lrNbAPjHPowGG
Please join us in congratulating Dr. Liau on her JEDI Trailblazer Award.
Linda M. Liau, MD, PhD, MBA
Chair of the Department of Neurosurgery
This prestigious award, co-sponsored by UCLA AAPI Faculty Alliance and DGSOM Justice, Equity, Diversity, and Inclusion Office, is given to faculty member who embodies leadership and excellence in advancing ideals of justice, equity, diversity, and inclusion.
Please RSVP here, and let’s celebrate her achievement on Friday, June 24, 5-6:30 pm.
Thanks Flipper44. You might be right. Your reasoning fits perfectly into my analysis of the trial. The missing MGMT data cannot come exclusively from the first 17 patients enrolled in the trial, IMO
The Danish Dude,
The “Innovative Medicines Fund” was announced almost a year ago. https://www.england.nhs.uk/2021/07/nhs-england-announces-new-innovative-medicines-fund-to-fast-track-promising-new-drugs/
It’s interesting to re-read Emeritus Professor of Neurosurgery Garth Cruickshank comments, IMO.
July 31, 2021
The Chair of the Brain Tumour Research Scientific and Medical Advisory Board (SMAB) Emeritus Professor of Neurosurgery, Garth Cruickshank feels that this IMF initiative appears to be very good news for brain tumour patients.
He said: “For glioblastoma multiforme (GBM) patients this a real step forward as their life expectancy is so poor that they may not live long enough to be well enough to take such a new drug or to benefit from it. Importantly, this initiative starts to unravel the conventional wisdom of having a long runway of testing before access to patients in a situation where such an approach has not borne much fruit in the last 30 years.”
However promising this sounds though, and we would hope that brain tumour patients such as those with recurrent GBM are early accessors to this programme, the fact remains that the drugs must be available for early access to be of benefit and for brain tumour patients these new therapeutic options just haven’t been available. The route to clinical innovation and new therapeutics remains underpinned by appropriate funding of the early-stage research that begins the translational pipeline.
11. The fastest way for a medicine to reach NHS patients is for a company to submit evidence of its clinical-and cost-effectiveness through a NICE health technology evaluation (i.e. technology appraisal or highly specialised
technologies).
12. Where NICE finds the case has not been made for routine use in the NHS
because it needs further data to resolve the outstanding uncertainty, the
Innovative Medicines Fund, as a managed access fund, has the potential to
significantly benefit patients by opening the opportunity for them to access
promising new medicines whilst this data is collected.
I asked him to clarify the censoring on the PFS curves and if he could tell us anything about the "smaller" unknown MGMT group. He forwarded the slide deck to me and told me it should contain the information I'm looking for. Smart guy!
Agreed. Unfortunately he wouldn't tell me the exact number.
Did one of the slides presented by Mulholland or Ashkan reference that there were a total of 9 patients that were mutated?
I had thought there were only 7 total patients in the entire trial.
Actually, the number of IDH mutations was, I think, seven patients out of 331, which is lower than what you saw in the comparator groups.
Elvisdk,
I have no experience with Dr. Thomas Nesselhut's therapy.
I would ask him if a dendritic cell vaccine is made from your own tumor lysate. (as with DCVax-L). I doubt it.
His treatment seems similar to the therapy of Prof. Stefaan Van Gool at IOZK -Cologne - Germany.
This quote is from the website "Doing it for Laura":
Professor Van Gool is our consultant at IOZK and we’ve now been going out there for a week roughly every month/6 weeks for 17 months, 13 of those have just been the standard electro-hyperthermia & Newcastle disease virus and 4 trips have also included the dendritic cell vaccinations. This is still pretty expensive, but the GoFundMe fund-raising has made this possible.
As well as the dendritic cell vaccinations we have also had tumour analysis done at CeGat, they then designed 2 neo-peptide vaccinations which were then made and administered at IOZK
We go out to Germany for 5 days every 6 weeks and Laura has an hour of treatment every day. It doesn’t have any significant side effects, and the only real discomfort is the amount of blood taken on the first day. Laura lies on a water bed and radio waves are applied to the area of her brain where the tumour was, the NDV is just a simple injection.
Elvisdk,
Here is a recent email address of Prof Ashkan’s secretary Katarina who will book you to see Prof should you so wish and take things forward for you.
ashkanpa@hcaconsultant.co.uk
So out of 571 patients, 7% were IDH mutated, so 40 patients.
And in the DCVax-L trial, 2% were IDH mutated, so 7 patients.
Good analysis. Thanks flipper44.
Thanks hoffmann6383!
sponsors should have a “quiet period” of a reasonable length to allow for the regulatory process of seeking approval for a new product or indication. Giving too much weight to the interests of secondary users and competitor sponsors in gaining access to data would in the long run present strong disincentives for clinical trialists to design and carry out future trials and for sponsors and their investors to develop and test new products and indications.
An important exception to the quiet period arises if a sponsor chooses to publish a manuscript prior to regulatory approval, as commonly occurs with important trials and novel therapies. In this case, the sponsor has put the results out for scientific and medical discussion and therefore should share the analytic data set supporting the publication—in essence, negating the quiet period. Once the scientific and medical community has read a publication with the sponsor's analysis and conclusions, the community should have the opportunity to scrutinize and reproduce the analysis and conclusions. Therefore, if the sponsor has elected to publish, the data supporting the publication—the post-publication data package—should be shared no later than 6 months after publication even if the product has not yet been approved.
Conclusion: It is beneficial to allow a “quiet period” while a product or indication is undergoing development for a regulatory application during which the full analyzable data set and metadata need not be shared unless the data are published.
Elvisdk,
Sending love & strength to you all!
Dr. Thomas Neßelhut, and his son and daughter, run their cancer clinic in the beautiful town of Duderstadt, Germany. Find out about his clinic and what he does in the film - Immunotherapy: The Battle Within | 2020 Documentary.
Min.30-
Thanks hmuney.
Lykiri, did you get your questions to slamminsalmon answered?
191 events on the DCVax-L PFS curve.
Who are those other 41 DCVax-L patients, LTFU?, temozolomide toxicity?,....
81 events on the placebo PFS curve.
Who are those other 18 placebo patients?
Terrific news Reg2015! Great to hear!
How many non crossover placebos alive at 3 -4 and 5 years after randomization?
How many IDH mutated placebos in the DCVax-L trial?
How many unknown MGMT patients in the DCVax-L trial?
Interesting paper online (published May 31, 2022)
Roel Verhaak, Fred Varn et al. compare DNA & RNA genomic tumor data from 304 patients with diffuse glioma to I.D. the most frequent changes taking place at recurrence, and provide a basis for new therapeutic strategies.
Link paper” Glioma progression is shaped by genetic evolution and microenvironment interactions.” https://www.sciencedirect.com/science/article/pii/S0092867422005360?dgcid=coauthor#bib25
Link PR May 31: “PREDICTING GLIOMA CHANGES BEFORE RECURRENCE”
By Mark Wanner
https://www.jax.org/news-and-insights/2022/may/predicting-glioma-changes-before-recurrence
In the GLASS cohort, the transcriptomic subtype of IDH wild-type tumors was found to shift between original diagnosis and recurrence in nearly half of IDH-wild-type tumor patients. Further investigation showed that these changes resulted from the commonly used chemoradiation treatment and associated changes in the types of non-cancer cells found in the tumor microenvironment. In contrast, most IDH-mutant tumors stayed proneural at both time points. The team summarized these changes into three distinct recurrence-specific phenotypes (collection of traits)—neuronal, mesenchymal, and proliferative—based on the cellular, genetic, and histological features that emerge at recurrence. Future studies are being developed to understand how these acquired characteristics can be exploited for making treatment more effective.
GermanCol,
Here is the link:
https://nwbio.com/wp-content/uploads/NW-Bio-Phacilitate-Presentation.pdf
meirluc,
Since the 232 patient treatment group is exactly 70% of the trial, one can estimate that 70% of the 162 documented unmethylated patients or 113 such patients are in the treatment group.
I am estimating that about 11% of the 64 crossovers or 7 were patients whose MGMT was unknown and that assumption is based on the fact that the MGMT status of 38 the 331 patients in the trial (11.48%) was unknown.
that leaves 57 patients of whom 55.7% or 32 patients can be estimated to be UMGMT.
Flipper44,
I always thought that ethical safety was the reason why 17 placebo patients were not allowed to enroll in the placebo group after August 2015.
I changed my mind after the release of the NYAS data. I think there is another reason why the 17 placebo patients are not enrolled.
The piece of data that surprised me was the 26,2% survival at 3 years from surgery for the 232 treated population, which I expected to be higher, given the previously reported blended 28,2%.
I admit that the recurrent performance was very impressive.
Back to the summer of 2015.
Remember Linda Liau saying “the patients in the trial do seem to be living longer” and her comment on the issue of pseudo progression.
I believe that in 2015 the FDA and NWBio (still blended) were aware that pseudo-progression was a major issue in the treatment arm of the DCVax-L study. (vaccine-induced infiltration of immune cells)
I believe both FDA and NWBio (still blinded) were aware that OS endpoints could not be within-study comparisons of DCVax-L patients vs. placebo patients, because placebo patients received DCVax-L following crossover.
I think the FDA and MWBio (still blinded) discussed the issues with the original endpoints and I guess the FDA was willing to accept the use of external controls.
If I’m correct it took NWBio 18 months to find acceptable data of external controls for the newly diagnosed patients and also acceptable data of external controls for the recurrent patients. ( Feb.6,2017 - NWBio announces lifting of clinical hold on DCVax-L by FDA)
I think if both FDA and NWBio were convinced (in 2015) that there was a way to get the new endpoints approved enrolling the additional 17 placebo patients would no longer be ethical, IMO
NOTE: I don’t buy the “early cross-over”. That would have destroyed the trial, IMO
Flipper44,
I think 3 DCVax-L patients are censored between 0 and 48 months from randomization.
1 around 6,5 months from randomization. (an unknown MGMT DCVax-L patient, IMO)
2 between 24 and 36 months from randomization. (at least 1 is a mMGMT DCVax-L patient, IMO)
It looks like 59 DCVax-L patients lived past 33 months from randomization. (36 months from surgery)
I think 31 placebo patients lived past 33 months from randomization. (36 months from surgery) Remember SNO 2018 update : 87 patients lived past 36 months from surgery and 3 patients censored between 35 and 36 months.
I have no idea how many of them are crossovers and noncrossovers.
Weren’t there less left censored patients in the 2018 SNO update?
Red_Right_Hand,
Thanks for sharing!
brainstrust@brainstrust
New #DCVax clinical trial results offer some much needed hope for the #glioblastoma community. Whilst this is positive news, we must be mindful of the challenges around parity of access. Read more on our website
https://brainstrust.org.uk/what-the-latest-news-on-dcvax-clinical-trials-means-for-the-community/
New #DCVax clinical trial results offer some much needed hope for the #glioblastoma community. Whilst this is positive news, we must be mindful of the challenges around parity of access. Read more on our website 👉 https://t.co/AHlTMB3XaU
— brainstrust (@brainstrust) May 27, 2022
Thanks Jack2479 and Sentiment!
I'm looking forward to seeing the peer reviewed publication describing the results in more detail but this could be a real shifting of the needle for #GBM treatment from @NorthwestBio https://t.co/wtA0W5FIfD
— Research@TheBrainTumourCharity (@BrainTumourCSO) May 26, 2022
David Jenkinson@BrainTumourCSO
"looking forward to seeing the peer reviewed publication describing the results in more detail but this could be a real shifting of the needle for #GBM treatment from @NorthwestBio".