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FDA approved the trial to commence and then again approved the trial to resume after a halt years ago. The trial was successfully completed.
https://virtualtrials.org/dcvax.cfm
That was a long time ago, but it was actually good because it facilitated a second approval of the trial design with crossover. After the halt, the trial was FDA approved to resume which constitutes a second and updated approval of its design.
https://virtualtrials.org/dcvax.cfm
https://clinicaltrials.gov/ct2/show/NCT04201873
Both groups are receiving DCVax-L
Group A (pembrolizumab, ATL-DC, poly ICLC)
Beginning 14 days prior to scheduled surgery, patients receive pembrolizumab IV over 30 minutes. After surgery, patients receive pembrolizumab IV over 30 minutes on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity.
Group B (placebo, ATL-DC, poly ICLC)
Beginning 14 days prior to scheduled surgery, patients receive placebo IV. After surgery, patients receive placebo IV on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity.
virtualtrials.org/dcvax.cfm
https://clinicaltrials.gov/ct2/show/NCT04201873
DCVax is filling the role of SOC in the Keytruda trial—you misunderstood—it is filling the role of SOC within the trial because every patient in both the experimental arm as well as the placebo arm are receiving DCVax-L.
NCI, Merck, & PHASE ONE are today supporting collaborators on the UCLA Keytruda trial—100% of patients in both the experimental group AND the placebo group receive DCVax. Only Keytruda in combo is being investigated—everyone receives DCVax as if it were SOC.
Group A (pembrolizumab, ATL-DC, poly ICLC)
Beginning 14 days prior to scheduled surgery, patients receive pembrolizumab IV over 30 minutes. After surgery, patients receive pembrolizumab IV over 30 minutes on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity.
Group B (placebo, ATL-DC, poly ICLC)
Beginning 14 days prior to scheduled surgery, patients receive placebo IV. After surgery, patients receive placebo IV on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity.
virtualtrials.org/dcvax.cfm
https://clinicaltrials.gov/ct2/show/NCT04201873
The pediatric trial approval is full approval and immediately actionable. There is no requirement for adult commercial approval or any prior application for adult approval for the pediatric trials to commence, however, the company has indicated that they will submit an application for adult commercial approval first. The second approval of the same trial design bodes well for the forthcoming adult application.
The trial design and its endpoints have been approved by regulators multiple times. Most recently, the MHRA issued final approval of the DCVax-L PIP:
On August 17, the Company received final approval of the Pediatric Investigation Plan (PIP) from the MHRA. The final regulatory approval of the PIP must be obtained before a sponsor may submit a Marketing Authorization Application (MAA) for approval to commercialize the new medicine for adult patients. The Company’s approved PIP includes a deferral under which the pediatric trials are anticipated to be undertaken after an MAA application has been submitted.
Patients will be treated with DCVax-L on the same treatment schedule as in the Company’s Phase III trial in adult glioblastoma patients.
The primary endpoint for each of the 2 pediatric trials will be overall survival, determined by comparing the survival of DCVax-L treated patients to matched contemporaneous external controls. The external controls will be identified using the same methodology as was used to pre-specify the external controls in the Statistical Analysis Plan for the Company’s Phase III trial in adult patients.
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
Yes, DCVax is filling the role of SOC in the Keytruda trial …
NCI, Merck, & PHASE ONE are today supporting collaborators on the UCLA Keytruda trial—100% of patients in both the experimental group AND the placebo group receive DCVax. Only Keytruda in combo is being investigated—everyone receives DCVax as if it were SOC.
Group A (pembrolizumab, ATL-DC, poly ICLC)
Beginning 14 days prior to scheduled surgery, patients receive pembrolizumab IV over 30 minutes. After surgery, patients receive pembrolizumab IV over 30 minutes on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity.
Group B (placebo, ATL-DC, poly ICLC)
Beginning 14 days prior to scheduled surgery, patients receive placebo IV. After surgery, patients receive placebo IV on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity.
virtualtrials.org/dcvax.cfm
https://clinicaltrials.gov/ct2/show/NCT04201873
What the regulators are willing to buy …
NWBO has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the Company’s Pediatric Investigation Plan (PIP). The development, regulatory review and regulatory approval of a PIP is a pre-requisite for application for approval of a new medicine for adult patients.
Patients will be treated with DCVax-L on the same treatment schedule as in the Company’s Phase III trial in adult glioblastoma patients.
The primary endpoint for each of the 2 pediatric trials will be overall survival, determined by comparing the survival of DCVax-L treated patients to matched contemporaneous external controls. The external controls will be identified using the same methodology as was used to pre-specify the external controls in the Statistical Analysis Plan for the Company’s Phase III trial in adult patients.
https://virtualtrials.org/dcvax.cfm
I love the fact that medical therapies must be examined and that there is a process that takes time and involves many people. Investors can wait. I do however struggle to understand from a patient’s perspective—why something proven safe must be so bogged down while the disease is so deadly. Could anyone imagine if we had repressed the COVID vaccines and tied up the process in red tape for years? There is a lot that the average person doesn’t understand about how drugs and new technologies reach the global market, but I can’t imagine how anyone could explain it to the dying.
Sure, we can say it that way:
In rGBM, mOS was 69% more than SOC.
But it is also correct to say that DVax-L mOS is 169% of SOC mOS.
You are correct. 128% would be awesome but it’s better than that:
A comparative increase would be 169%
13.2 is 169% of 7.8 if you are talking about OS in recurrent.
DCVax-L OS is 169% of SOC OS for recurrent GBM.
Additionally, the recurrent tails are astonishing. The data represents months or survival becoming years of survival.
Wow—this really is a gem and a breakthrough… the more I read and compare other trials, the more DCVax-L shines — The methylated subgroup, older group, recurrent group, the incredible tails…the data have great meaning and invaluable implications to the field of immunotherapy in oncology if anyone really looks at it …and this is just the tip of the iceberg of its possible uses in other cancers…
Just one of many examples that caught my eye was from the recent Nivolumab GBM trial JAMA article:
“Nearly all patients experience recurrence following standard-of-care surgical resection, radiotherapy, and temozolomide. Treatment options at recurrence are limited, and no therapy has prolonged overall survival (OS) in this setting, which underscores the need for novel therapeutic interventions in this patient population”
DCVax-L had an amazing impact on the OS in the recurrent group and an astonishing tail.
Am I correct to assume that the journal will come in May? The final comment from the audience yesterday came from someone who identified himself as “one of the 70 authors” and he alluded to the coming ASCO presentation. Maybe he was just noting that he was one of the 70 clinical investigators—I’m not sure, but it seems as if the journal would have to come before NWBO presents in June.
Musellafoundation published another video from yesterday that includes about ten minutes of Q and A that the previous videos had cut off. I think I hear Dr Bosch from NWBO answering some of the questions… on YouTube 41:45 minutes long
Now that we have seen the core data, it seems that approval would be the best path forward to further develop the technology and to maximize the benefit of DCVax-L as a platform since it is incredibly safe and has proven efficacy. Any RA holding back such a safe and effective therapy simply would not make sense. Doctors and patients using the therapy would only serve to inform its application beyond GBM and accelerate other trials that include DCVax-L or other agents. Data collection and analysis only continue after approval and approval opens up a vast new universe of possibilities.
I would think that confirming safety on balance with potential benefit are all that RAs should be doing in their role, and then they must pass the baton to the doctors in the field who take it from there. DCVax-L is certainly ready to graduate to the stage where it can be used by doctors in the field where it now belongs. After liberation from clinical trials, It will advance the science of immunotherapy and enlighten new paths forward where toxic and otherwise harsh therapies are not always the only option. Beyond extending lives, the learning and discovery that would come from its use on a larger scale would be invaluable.
If the world is right side up in this case, and day is not night, then I would expect swift movement toward approval and toward advancing the science.
Thanks for all your commentary on NWBO. As a layperson in this area, I can only say that I would want DCVax-L if I were a cancer patient and I believe it has double-digit value in terms of billions of MC value as a result of its advancement of the science of oncology…
I have to say that the manipulation and misinterpretation didn’t upset me today as much as the rollout of TLD. I have great respect for the trial participants and doctors and I was annoyed by the PR linking to the virtualtrials.org website. I know I should get over it, but it just sticks in my craw that NW Bio posted a URL to a website that literally posted a video of the stock price tanking juxtaposed the doctor’s presentation. It was inappropriate and disrespectful to everyone who worked on this for years. Luckily the video has since been removed, but I was appalled. The video reduced DCVax-L to a real-time share price and the company linked to the video. I really think that the scientists and trial participants deserved better.
NWBO and DCVax-L technology represent a miraculous and invaluable scientific achievement. It is truly a significant leap forward toward understanding and curing cancer. Its significance has nothing to do with a share price. If the share price reflects reality in the coming days, it will easily be in double digits.
Well I just meant that the helmet device was approved and is on the market, so it might be an interesting comparison in terms of efficacy data. I was thinking that if a hat was approved then DCVax-L should definitely also be approved. Based on the data and considering the fact that a patient must wear the Optune device all the time, I would choose the vaccine over a hat device. I know that the considerations can’t be simplified like I just did, but I’m just thinking generally about what gets approval and why.
I wonder whether it is useful to draw comparisons with Optune to enlighten the value of NWBO.
I can’t get past this bumbling of an announcement of brilliant data: On their corporate website, NWBO posts a link to a website that posts a video of the share price falling. It’s not the best way to showcase TLD for the first time.
The NYAS presentation is only 30 minutes long. Hopefully the journal and other announcements will follow in swift succession.
One quarter notice for major changes is what I wud expect from Vanguard. I was surprised. I was also in the middle of a strategy.. if one of my other stocks popped over the next few weeks, I was planning to use the opportunity to pick up more NWBO. I know that scenario is unlikely to play out, but if it happened I would be irritated that my hands were tied with almost zero notice.
I hate making changes, but it went fast and well. I inspected each and every NWBO share when it arrived to be sure none were scratched or bruised… everything was fine.
Moving holdings from Vanguard to Fidelity was quick for me. When I received the OTC notice, I opened the new account and the transfer was completed within 3.5 days total (they estimated 5). I really think Vanguard’s 10-day notice was abrupt and unacceptable. The change is fine, but any change should come after a 90 day notice in my view.