Sunday, 13 August 2017

DCVax-L presentation at ASCO 2017, June 5

The most recent public information on the phase 3 DCVax-L trial was given in the form of a presentation with slides by Dr. Marnix Bosch, chief technical officer of Northwest Biotherapeutics, during the recent ASCO conference in June. The presentation covers both DCVax-L and DCVax-Direct.

The DCVax-L (phase 3 trial) part of the talk is from approximately minute 6 to minute 25.  The most interesting part where new information is presented is from approximately minute 17 to 25.  The remainder of the presentation is devoted to DCVax-Direct.

Watch the video here:
https://www.nwbio.com/dcvax-novel-personalized-immune-therapies-solid-tumors/

Here are some slides from the talk:







We can assume based on this presentation that the threshold for the overall survival analysis to begin has now been reached and is likely underway.  He mentioned that a publication of the preliminary data is in preparation.

The only survival data publicized so far is for the patients who were excluded from the trial due to early progression and were given DCVax on a Compassionate Use protocol, aka the "informational arm".  In the "indeterminate" subgroup of 25 patients within this informational arm who had early evidence of progression followed by a period of stability, 40% have made it to nearly 3 years or more, and 24% have made it to 4 years.

24% surviving at 4 years compares very favorably with the control arm (receiving standard of care) of the recent phase 3 Optune trial, which had 10% surviving at 4 years, and the study arm (standard of care + Optune) of that trial had 4 year survival rate of 17%

It would be reasonable to expect survival outcomes in the phase 3 trial to be better than those from the indeterminate group of the "informational arm" given that the latter group was excluded from the trial for at least some form of evidence of early progression, while patients included in the trial had no evidence of progression.

The next step to improve outcomes further is now being taken by UCLA, where a phase 2 trial is slated to open soon combining DCVax-L with nivolumab (anti PD-1), although this trial is for recurrent, rather than newly diagnosed GBM.
https://clinicaltrials.gov/ct2/show/NCT03014804



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