Presentation at the New York Academy of Sciences on Final Results of DCVax-L Phase 3 Trial Showing Impressive Efficacy (Part 2) Incredibly Low p-Values on Median Overall Survival Endpoints
Earlier today, I put out the first of a series of reports that I plan to issue on this presentation. As I write this, the stock is down over $1.00 even through the results were extremely, extremely impressive. The presenter of the paper stated that DCVax-L represented the first major advance in treating glioblastoma (GBM) since the approval of temozolomide 17 years ago. Audience participants agreed with this statement and so do I.
To my amazement and probably any objective person listening to the presentation, the stock was hit with an enormous amount of shorting, probably most of which was illegal. Hedge funds usually have paid bloggers who put out negative information that seemingly justifies this price behavior. The latter are stating that the trial failed because it was not statistically significant on the median progression free survival endpoint and that regulatory agencies will not accept historical controls for the control arm. In my earlier report, I intended and I believe I succeeded in debunking these arguments.
Now I will go through the actual data that was presented at the New York Academy of Sciences which is shown on this link. My approach will be to refer to pages in the slide deck that was presented today. You can follow along to see my comments on certain pages. This is my first brush and I will follow with more comments in later reports. The key findings of the trial were as follows; these results are far beyond impressive.:
Note that Kaplan Meier analysis showed that DCVax- met the median overall survival endpoint in newly diagnosed GBM with a strong p value of less than .002. In recurrent GBM, DCVax-L met the median overall survival endpoint with a p value of less than .001. Remember p less than .05 is usually required for approval. DCVax-L blew the doors off on these endpoints.
The survival tail in ndGBM showed 13.0% of patients alive at five years versus 5.7% in control group. This is every bit as impressive as survival tails for the checkpoint inhibitors in recurrent non-small cell lung cancer and recurrent melanoma, cancers which are roughly equivalent to glioblastoma in terms of survival. Note that it was the demonstration of the survival tail that made Merck’s Keytruda and Bristol-Myers Opdivo multi-billion drugs.
The survival tail for DCVax-L in recurrent GBM showed that at 30 months 11.1% of GBM patients were alive versus 5.1% in the control arm.
Page 10
Median progression free survival was not the primary endpoint in the trial so before the trial was unblinded, overall survival was designated as the primary endpoint. Obviously median overall survival is the gold standard end point for any oncology trial.
Pages 12, 13
Cross over design of the trial required the use of results from the control arm of GBM trials that ran concurrently with the DCVax-L trial. Fortuitously, this allowed for the trial to show median overall survival in both newly diagnosed and recurrent GBM.
Pages 13 to 21
The methodology employed to determine results in control groups from other GBN trial that ran concurrently. Note on page 13 that this was done by an independent expert firm (not Northwest) that selected the most closely matched patient populations using 14 criteria: i.e. contemporaneous, same patient population, same SOC, RCT design, etc.
Page 23
The study achieved statistical significance on the primary endpoint of median overall survival in both newly diagnosed and recurrent GBM.
Page 24
Key data points showing results for DCVax-L versus historical control arm.
Page 29
Kaplan Meier analysis shows that DCVax-L met median overall survival endpoint in newly diagnosed GBM with a strong p value of less than .002.
Page 30
Survival tail in ndGBM showed 13.0% of patients alive at five years versus 5.7% in control group. This is ever bit as impressive as survival tails for the checkpoint inhibitors in recurrent non-small cell lung cancer and recurrent melanoma, cancers which are roughly equivalent to glioblastoma in terms of survival.
Page 39
Kaplan Meier analysis shows that DCVax-L met median overall survival endpoint in newly diagnosed GBM with a strong p value of less than .002.
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