This is a chance to learn about Optune - or for those of you using it - to meet others using it and swap tips and ask the experts any questions you have! Most are live but the last one is a webinar.
They should have done this a long time ago. I hope this becomes available for patients soon. The delivery method should be approved separately from the drugs used - so we can mix and match drugs based on a patients' genetic profile.
SNO is an amazing meeting. Aside from all of the presentations, I got to meet and talk with many brain tumor researchers and physicians and discuss what they think are the best treatments, what is needed to advance the field, what is slowing down progress and much more.
We also were able to interact with many other brain tumor nonprofits. There was some resistance in the past to working together but I think the last barriers were recently removed and you are going to see a lot more collaboration now. We are all about collaboration. Working together we will be able to accomplish much more than any of us could individually.
This shows that Optune has finally hit the mainstream. 55 presentations at the major European brain tumor conference. Many of these are looking at ways to improve the outcomes, including new types of arrays, new placement of arrays for tumors lower in the skill and for pediatric patients.
Comparative Study of Adjuvant Temozolomide Six Cycles Versus Extended 12 Cycles in Newly Diagnosed Glioblastoma Multiforme. 6 months of Temozolomide for newly diagnosed patients became the standard because the original trials specified 6 months. That was done to speed up the trials. They didn't try various lengths of time and picked the best. This study looks at using 6 vs 12 months or Temozolomide. It is a small study - so you have to be careful, but using the 12 months of temozolomide increased overall survival by over 50% but did triple the chances of having toxicity.
Now that the 3 largest private health insurance carriers in the USA cover Optune, the rest should follow suit soon! This is a major victory in the fight against brain tumors. We thought the hard part was going to be getting FDA approval because it is a completely new type of treatment, but that actually was easy since the data supported it. Once that happened, I assumed patients would be able to just get it but the timing was terrible. Insurance companies have just started fighting back against expensive treatments and started denying all new treatments as a way of saving money until they are forced to pay for them. It was a long, hard battle but the people at Novocure persevered and won the battle with the private insurers.
Next up is Medicare. I had multiple meetings with Medicare and they are getting close to approving payment. The people I met with at Medicare understand that brain tumor patients need this treatment and they are trying to find a way to pay for it. Having the majority of private insurance companies paying for Optune, along with the recent publication of data in the Journal of the American Medical Association, should allow patients to appeal Medicare rejections successfully. IF you have a problem with a Medicare rejection, call me at 888-295-4740 and maybe I can write a letter for you to help with the appeal.
I tried to get something very similar off the ground years ago, but couldn't raise the money needed for it. I had the major brain tumor centers and another brain tumor foundation willing but it was too expensive for us. I hope this group does well. I think it is the fastest and cheapest way to find the best drugs and combinations.
This is historic. As far as I know, and I have been involved with brain tumors for 22 years, this is the first time a GBM trial was ever stopped early because it actually worked! Optune – the new name for the FDA approved Novocure tumor treating field device, has finally shown what it can do. This was a large phase 3 randomized trial comparing the standard “Stupp Protocol” to the standard + the Optune device. There are many ways to look at the results (see the article for the rest) but keep in mind the numbers given are from the time the trial started, not from the date of diagnosis. The trial started around 3.8 months after diagnosis. There was an increase of about 50% in the number of patients alive at 2 years after starting treatment ( about 27.8 months after diagnosis) , from 29% in the Temodar group to 43% in the Optune group. Overall survival increased by about 3 months, from 16.6 to 19.9 months after trial started ( or about 20.4 to 23.7 after diagnosis).
Dr Stupp presented the data and then said "a new standard of care for patients with GBM has been established", and "A new cancer treatment modality has been born". He called it a paradigm shift.
The last time the standard of care changed was in 2005 when Dr Stupp presented his data on using Temodar at the same time as radiation, in addition to the old way of using Temodar. That resulted in a gain of 2.5 months, from 12.1 months to 14.6 months from diagnosis.
My opinion is that this is a big step forward, with very little downside. This is the first non-toxic therapy ever to succeed in a phase III trial for newly diagnosed cancer patients. I agree it should be the new standard of care. Of course a lot more work needs to be done but we have to go with the best we have at the time and this is it. I hope to see more trials combining other treatments with Optune – hopefully also with no or low toxicities. This brings us a step closer to our goal of a cure.
Talking to many of the doctors present at the meeting, there were still a few who said they wouldn’t use it. The main objection now is that it may interfere with clinical trials. I would suggest designing trials to allow for the use of Optune just as they had to do when the standard of care changed 9 years ago. I am a huge supporter of clinical trials but if there is a choice between using Optune and having minimal or no additional side effects with a known average benefit of a 50% better chance of living at least 2 years, vs. a clinical trial which has unknown side effect profile and unknown benefit in survival, I would probably choose the Optune.
If you decide that you want to try this treatment, ask your doctor about it but if they seem resistant to the idea, go to http://optune.com to find a doctor in your area that is trained to use it and get another opinion. This treatment has been FDA approved for recurrent glioblastoma, but it can be prescribed off label for newly diagnosed. Clearly the earlier you start it the better the outcome. Hopefully the FDA will approve it for newly diagnosed GBM soon!
Disclaimer: Novocure is a sponsor of the Musella Foundation but I have never personally received anything of value from them.
Dr Schulder is on our medical advisory board and one of my favorite brain tumor neurosurgeons.. he is doing a trial of rindopepimut (which used to be known as cdx-110). This is a vaccine against the Epidermal Growth Factor Receptor version 3(EGFRvIII) , which is a mutation of the EGFR which is found on normal cells. (The article is wrong on that point). If EGFRvIII is found on your tumor, it is a bad sign - the tumor is of the more aggressive variety because this receptor makes the tumor grow faster. This vaccine inactivates the EGFRvIII. The hope is that it can stop the tumor from growing, or even if it fails, it might be able to convert the tumor into a slower growing tumor with a better prognosis.
Best part is that it is relatively easy injections into the skin - not into the brain.
(Disclosure: the company that makes rindopepimut is a sponsor of our foundation, and Dr Schulder is on our medical advisory board)