ERC Belgium Submits Marketing Authorization Application to European Medicines Agency (EMA) for Glioblastoma Immunotherapy, SITOIGANAP
This is great news for Europe. This vaccine was shown to be very safe, and early results show that it helps some patients, with more than 10 % of recurrent GBM patients survived over 3 years which is pretty good. They are applying for a conditional approval in Europe. Here in the USA we do not have conditional approvals yet and it will take another few years to make this available in the USA. I am working on a bill that would allow the conditional pathway to be used here in the USA. I will write a news blast about it in a few days!
DelMar Pharmaceuticals Presents Positive Interim Data on VAL-083 Demonstrating Favorable Outcomes in Both Newly- Diagnosed and Recurrent GBM at the AACR Virtual Annual Meeting II This is sort of mixed results contrary to how the headline reads. In newly diagnosed MGMT unmethylated glioblastoma (this is the worst category of glioblastoma) , they reported about a 2 month improvement in progression free survival compared to historical data on temozolomide, which is good but for recurrent MGMT unmetylated glioblastoma, the did about the same as historical controls.
Bottom line - more research needs to be done to find ways to make it work better. It obviously has some effect but they need to work on how best to use it, why it doesn't work as well as we hoped and how to fix that. I think it will have a place in the ultimate cocktail, replacing temozolomide for MGMT unmethylated patients. Remember - temozolomide was rejected by the FDA the first time the FDA was asked to approve it because early testing did not show an improvement, but then later studies showed the major benefit that makes temozolomide the standard of care.
I did not see the full text of this (they wanted to charge $39.95 to see the full article and it doesn't look like it is worth it) so my comments apply to the abstract which is freely available on the internet.
From the wording of the abstract, it is unbelievable that a journal like Neuro-oncology would publish this biased nonsense or that it got through the peer review process.
There are some doctors that are skeptical about this therapy which is FDA approved. That is true. There are about 800 hospitals in the USA that do use it so it is not the majority who are skeptical. That is a subjective feeling about the treatment and it might be ok to say it in the introduction - but does not belong in the conclusion if it is not supported by the research cited.
In the results, they say there were 852 studies, but only included 9 of them, with 1191 patients. They also say that it improved survival in newly diagnosed glioblastoma (and not in recurrent).
The conclusion should be based on the methods and results which are hard data - not to include subjective pre-conceived notions about "concerns" that some doctors may have. They never said they surveyed doctors to see how they feel about Optune.
There has never been a phase 3 trial in adult glioblastoma that had better results than the Optune trial for newly diagnosed. The concerns about the trial design were dispelled at the Medicare hearings. (Mostly the question is why not use a sham device in the control group. The answer is it was impractical and unethical as the sham device would require patients to shave their heads and apply a fake device for 2 years without any chance of benefit, and besides, the final endpoint was overall survival which can not be affected by the bias of the doctors knowing who gets the treatment or not).
The conclusion mentions "concerns" about the quality of life, which was addressed in many of the studies. Who has the concerns? The majority of patients would prefer a skin rash and annoyance of using the device to using a wheelchair or coffin. Or of using any other treatment that has worse side effects and has not been shown to help as much as Optune. Patients should be given the choice. It is ok if they do not want it but for an author to project their own biases onto patients without research is not typical of a peer reviewed article.
It then goes on about concerns over the cost of therapy. The cost of everything is sky high today (we are working on that with the Promising Pathway Act). Optune cost about half of the price of Avastin (per month), which has never been questioned. The phase 3 trials reported the largest ever improvement in survival for newly diagnosed patients on Optune compared to NO increase in survival for Avastin. I know of no patient who wanted Optune that was not able to get it due to the cost. Almost every insurance plan covers it and there are programs to help pay.
And finally they suggest further investigation is needed. There were 852 studies so far. What chance is there that another study is going to sway the handful of doctors who are biased against this treatment?
I do agree we need more research to find combinations that make it work better, but the way they said it, we need more research to provie it works which has already been proven!
Disclosure: The companies that make Optune and Avastin are sponsors of our organization. (And I am a fan of both Optune and Avastin).
