First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma
This article is so important that I am placing my editorial comments into the full text part of this entry so more people see it, along with a link to the full article.
Posted on: 05/29/2018
For Full text go to: https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6
Editor's (Al Musella, DPM, President Musella Foundation) Comments:
This article reports the interim results of the DCVax phase 3 trial. This was a large, blinded, randomized trial where initially 2/3 of the newly diagnosed patients received the vaccine and 1/3 received a placebo. At the time of recurrence, patients were allowed to cross over and take the vaccine. Most chose to take it, so almost 90% of the patients in the trial had the vaccine, either as newly diagnosed or recurrent.
The results are unbelievably good. These numbers include patients who did not get the vaccine at all and those who got it after recurrence – so they are probably lower than the final numbers will be.
Among all patients who started the trial, the median overall survival from time of first surgery was 23.1 months.. The previous best reported results in large trials, were about 22 months for Optune combined with Temodar, and about 16-17 months for Temodar alone and about 15-16 months for Temodar combined with Avastin.
To look at the long term survival tail, they looked at patients who started the trial over 3 years ago Of those first 182 patients, (including those on standard of care plus placebo) 44 of them (24%) lived over 3 years, and the Kaplan-Meier median survival estimate for these patients is an amazing 88.2 months. Historically less than 10% of GBM patients live 3 years or longer.
Of the 331 people in the trial, 100 are classified as "extended survivors" who lived an average of 40.5 months, with a few living more than 7 years. This is unheard of with Glioblastomas.
These are interim numbers, and they could get better or worse with time as the data matures and they unblind to analyze those who got the vaccine as newly diagnosed. However, even these interim results are good enough in my opinion that GBM patients should be clamoring to get this.
They report on subgroups that have even better results, but the results on the entire group are enough to say it is worth using for a glioblastoma patient even without looking at the subgroups. That is a sign that the treatment is working.
The key is that this is a simple shot in the arm with minimal side effects and very little disruption in the life of the patient. Before radiation, they obtain immune cells through a blood draw process that takes a few hours but is only done one time to produce enough vaccine for the entire course of treatment. A fresh or frozen tumor sample is also needed, as this vaccine is custom made to each patient’s tumor. Then there are 6 injections in the arm the first year, then only 2 per year after the first year. These injections are similar to the flu vaccine – a quick relatively painless job, not hours on an infusion unit. It does not cause you to lose your hair, become nauseous, or interfere with your blood counts.
This is only the beginning. Theoretically, DCVax can be combined with other treatments to make it work better. We need this treatment available now. If you are interested in it, contact me and we will fight together to get access quicker. Email me at email@example.com or call me at 888-295-4740. We will be discussing this in the braintumor treatments online support group at https://virtualtrials.com/braintumor-treatments.cfm
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