Wednesday, May 05, 2021 10:09:41 AM
spartex, my opinion and position is:
(1) DCVax-L will be approved for all gene types
(2) DCVax-L benefits all gene types, but it benefits some gene types more than others
I do agree that DCVax-L does help some patients more than it helps other patients.
But the interim blinded and blended data that was released suggest that it helps all or most patients to a degree. For example, in the interim study released in 2018, the median survival for methylated MGMT gene status patient was 34.7 months, compared to the historical average of 21.7 months for SOC. That is a survival increase of 13 months.
The median survival for patients with unmethylated MGMT gene status was 19.8 months compared to a historical average of 12.7 months for SOC. That is a survival increase of 7.1 months.
It does appear that patients with methylated gene status benefit more than patients with unmethylated gene status, but all gene status patients benefit some. Also, keep in mind that these number are blended and they include the control group as well. The actual numbers just for the treatment group will be even better.
Also, I wanted to add that the Stupp Protocol (surgery + radiation + chemo), the current SOC for GBM, only added an average of 2.5 months of survival benefit, and it was approved by the FDA for all gene status patients. That is a lot less than the DCVax-L median survival benefit for all GBM patients, a minimum of 7 months
(1) DCVax-L will be approved for all gene types
(2) DCVax-L benefits all gene types, but it benefits some gene types more than others
I do agree that DCVax-L does help some patients more than it helps other patients.
But the interim blinded and blended data that was released suggest that it helps all or most patients to a degree. For example, in the interim study released in 2018, the median survival for methylated MGMT gene status patient was 34.7 months, compared to the historical average of 21.7 months for SOC. That is a survival increase of 13 months.
The median survival for patients with unmethylated MGMT gene status was 19.8 months compared to a historical average of 12.7 months for SOC. That is a survival increase of 7.1 months.
It does appear that patients with methylated gene status benefit more than patients with unmethylated gene status, but all gene status patients benefit some. Also, keep in mind that these number are blended and they include the control group as well. The actual numbers just for the treatment group will be even better.
Also, I wanted to add that the Stupp Protocol (surgery + radiation + chemo), the current SOC for GBM, only added an average of 2.5 months of survival benefit, and it was approved by the FDA for all gene status patients. That is a lot less than the DCVax-L median survival benefit for all GBM patients, a minimum of 7 months
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