Background: Standard of care (SOC) and patient survival in glioblastoma have changed little in the past 17 years.
We evaluated in a phase 3 trial whether adding an autologous tumor lysate-loaded dendritic cell vaccine (murcidencel) to SOC extends survival. Patients and
Methods: Newly diagnosed glioblastoma patients were randomized 2:1 to either murcidencel or placebo.
Under a crossover design, all patients could receive murcidencel following tumor recurrence. All parties remained blinded regarding treatments before recurrence. Patients thus received murcidencel at new diagnosis (nGBM) or at recurrence (rGBM) following crossover from placebo.
“The development, regulatory review and regulatory approval of a PIP is a pre-requisite for application for approval of a new medicine for adult patients, such as DCVax®-L.”
“The Company submitted its proposed PIP to the MHRA in February 2022, and has been going through the regulatory review process since then. On August 17, the Company received final approval of the PIP from the MHRA.”
1/ "Only 5% of glio patients survive for five years. So how stunning is it for DCVAX-L to see life expectancy at 60 months rise from 5.7% to 13%, an increase of 228%. Some patients have seen total remission glio and are cancer free more than a decade after treatment.
2/ For example, Brad Silver participated in the Phase 1 trial 17 years ago and is cancer free now."
If you watch this by idea closely, you’ll note that the trial coins not proceed ethically UNLESS it was a crossover style. But all the patients lived longer including the recurrent ones who got access to #DCVaxL late. THAT was their placebo arm originally. There is no way in hell
, in my opinion, that a regulator is going to push a drug company into a crossover trial ethically, and then say, oh, man, your drug is so successful in making everyone live longer, but there is nothing that can be done. You fail! That’s not how regulation works.