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Brain Tumor News!


Note: The comments under each article title are the opinion of our president, Al Musella, DPM, and do not reflect official policy of the Musella Foundation!

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07/20/19 A Randomized Double-Blind Placebo-Controlled Phase 2 Trial Of Dendritic Cell Vaccine ICT-107 In Newly Diagnosed Patients With Glioblastoma        

 This is the final report on the phase 2 trial of ICT-107 for newly diagnosed GBM.  It was declared a "failure" because the median survival did not improve enough.  However, digging into the details, there are many patients who responded very well, and there were no side effects.   As with the other immunotherapy trials, this had a long survival tail which does not get reflected in the mean survival statistics.  I still feel this is a worthy treatment to try. 

 I just heard (and reported in a recent news blast) that this vaccine is making a comeback - it was sold to a new company who hopefully will run another trial in the subgroups that benefitted!

 




07/19/19 Study hints at why an aggressive form of brain cancer is hard to treat        

 Very important article.     It points out how the tumor is usually made up of at least 2-4 different subtypes of GBM, and most importantly, that the cells are able to change from one type to another.  This may account for how easily a tumor evades treatments. It also opens up a lot of possibilities such as targeting the mechanism that the cells use to change back and forth - perhaps have them all change to an easier cell to kill, Or just target the four subtypes with 4 different treatments and the cells would have no place to hide!

 




07/19/19 A New Method for Ethical and Efficient Evidence Generation for Off-Label Medication Use in Oncology (A Case Study in Glioblastoma)        

 They report early results using a combination of 4 off label, easily available drugs for the treatment of GBM




07/18/19 Medicare Releases Final Local Coverage Determination Providing Coverage of Optune® for Newly Diagnosed Glioblastoma        
Medicare published the final rule this morning.  This is the one that we have been battling for the last few months, trying to get them to remove the proposed restrictions.   Medicare listened to every comment  we sent. (Their point by point  response is in the link on the article below), and removed the worst ones.  We can live with it the way it is. Not perfect, but much better than the proposed rule. I call our campaign a win!  The brain tumor community came together on this one.  There were 301 comments submitted, 5 from advocacy groups (including the Musella Foundation), and 209 from patients or caregivers, 80 from doctors!  Very impressive. Thanks!
 
They removed the big restriction on where you had to go for treatment. 
 
As for surgery, we commented that some people can't get "maximal debulking surgery". So they did not remove that requirement, but did add the words "where feasible". which effectively removes that one!
 
They did keep the need to start within 7 weeks of the end of concomitant chemotherapy, but did change from "Temodar" to "chemotherapy",  so those that are use a different chemotherapy are still covered. 
 
They kept the restriction on using Optune for 18 hours a day but added an exclusion for those days that you have to limit or interrupt treatment,
 
They did not change the need to have no evidence of progression but in their comments they mentioned the RANO criteria considers pseudoprogression. Reading the RANO criteria closely, for the time period in which the decision needs to be made, it is hard to claim it is progression even if the MRI is 
worse - so I do not think this will be much of a problem.
They did not remove the karnofsky score of 70., and the need for it to be a GBM.
They also added a way for people who were already on Optune and then switch to Medicare can continue if they are using the device and show it is helping.
 
And they opened the door to appeals if you do not meet any of the criteria!
 
Overall, much better than I thought we would get, and it was much faster than I thought!  Thanks to Medicare for conducting the process in the right way.
 

 




07/17/19 Electricity helps control man’s brain tumor        

 The doctor mentioned, Dr Peereboom, is one of the best neuro-oncologists in the world, and one of my favorites.  However, I disagree with what he says in the article. He talks about the average benefit is living 5 months longer with Optune than without.  That is true but I look at it in a different way. I would probably not choose something that only adds 5 months to the average survival (if there were any other choices).  I look at it as your chances of being alive in 5 years goes from about 4% without Optune, to 29% if you use Optune with at least a 90% compliance rate.  That is definitely worth choosing.




07/17/19 ImmunoCellular Therapeutics Announces Asset Purchase Agreement with Private Biotechnology Company        

 This is great news.   ICT-107 is an off the shelf vaccine for GBM.  The early clinical trials looked very good, but the final clinical trial "failed" and they stopped development of it.  However, there were quite a few responses and long term survivors from that trial.  There were probably some mistakes made in that trial design.  Patients that had certain biomarkers did well enough (adding over a year  to median time to progression compared to those without the biomarker)  get FDA approval but patients without those biomarkers had no benefit. Hopefully this new company will run the correct trial and make this vaccine available.  This is literally a shot in the arm (or leg) with the same side effects profile as the flu shot, and there are a few long term survivors out over 7 years who are not only alive, but in good shape, happy and still working.




07/16/19 GBM Awareness Day This Wednesday July 17th!        

 Please look for the hashtag #GBMDay on social media on Wednesday and retweet it so we can get it trending!




07/16/19 Attend an Optune Open House.        

 From our friends at Novocure!   




07/16/19 Neoadjuvant Anti-PD-1 Immunotherapy Leads to Survival Benefit in Recurrent Glioblastoma        

 This is the second publication which conforms that if you are going to have a surgery, it pays to start taking pembrolizumab before the surgery and continue after, instead of starting after.




07/15/19 Phase II study of Dovitinib in recurrent glioblastoma.        

 Unfortunately this treatment did not work.




07/06/19 Insurance type impacts the economic burden and survival of patients with newly diagnosed glioblastoma.        

 As expected, the better insurance you have the better you will do.  This is very significant when we start talking about Medicare for all.  The most popular "medicare for all" plan really is Medicaid for all. It sounds good with no copayments or deductibles, but when you try to limit costs especially for complex cases like a brain tumor, quality has to suffer.

One fault in the article- it says Medicare patients do not live as long as private insurance payments, but they did not correct for age.  Medicare patients are usually older than private insurance patients, especially at the time of the first surgery.  Older people in general do not do as well as younger people.

 

 




07/01/19 Defeat DIPG Executive Director Jenny Mosier Speaks at FDA Public Hearing Regarding ONC201        

 This is one of the most moving speeches about how devastating pediatric brain tumors are and the need to speed up development of treatments.




06/25/19 Integrating Clinical Research And Care In A Perpetual Trial        

This is the wave of the future. It combines everything needed to speed up the search for the cure: finding the best treatments for each individual patient, helping them to get access, and analyzing the results so we learn from each patient.   Instead of trying to find the right patients for a specific treatment, this turns it around and finds the best treatment for a specific patient.

The Musella Foundation is partnering with xCures and Cancer Commons to run compassionate use programs in a new way where we collect the real world data to help speed up drug approvals and learn best how to use drugs.

Disclaimer: I own stock in xCures, and am a consultant for them.




06/24/19 Musella Foundation awards 9 grants!        

 Our largest grant was a payment of $250,000 towards a $1 Million pledge we made to open the compassionate use program for the experimental drug ONC-201 in the USA, and to track the patients so we learn from every patient's experiences.   We are now saving for the next payment, due at the end of this year, as well as another $2 million to open the program in the rest of the world!

 

 




06/22/19 Bayer’s regorafenib kicks off brain cancer platform trial        

 This is the opening of the GBM AGILE trial, which will allow drugs to be tested much faster and easier for GBM. New drugs can be added and underperforming drugs dropped to home in on the best treatment or combination of treatments quickly!

I wish them luck!

 






06/22/19 New Data Demonstrates Safety Profile of GammaTile Therapy for Various Brain Tumors        

 GammaTile is an fda approved treatment which is an implant that slowly releases radiation to the tumor bed.  See more details from our recent webinar on it at:  https://virtualtrials.com/video2019.cfm?video=201905




06/13/19 Webinar: Personalized Approaches to Treating Cancer Explained in Plain Language        

 This is from our friends at Store My Tumor.Com   They provide services to store and freeze your tumor sample from surgery, as well as help you get access to the services that can use this tissue such as specialized testing and even the creation of custom made vaccines!




06/12/19 Glioblastoma Awareness Day Resolution Passes U.S. Senate with Unanimous Support        

 Great job by the people at the National Brain Tumor Society to get the Glioblastoma Awareness Day passed!




06/11/19 Oncology Expert Keith T. Flaherty, MD Named Chairman of xCures Scientific Advisory Board        

 The virtual trial they are talking about is the next generation of our virtual trial registry.  It takes the giant leap into offering ideas for treatment options.  Our program never suggested anything - just observed what patients did and the outcome.  This new program will evaluate each patient and come up with ideas for treatment options that fit their specific profile.

Disclaimer:  I own stock in this company and am a consultant for it.




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