Thursday, January 24, 2019 5:11:15 AM
If, however, you add on the median 3.8 months from surgery to randomization, then you would be looking at 10.5 months v 7.8 months. Which would be an improvement of 34.6%.
So two sets of figures for the same patients.
One appears to show an improvement in median PFS of 67%.
And the other set is 34.6%.
All depending on where you set the start line.
On this metric, the delta in favor of Optune appears a lot better if you go from randomization.
The shorter term OS milestone figures, and indeed median OS however, appear better if you measure from surgery.
In their final analysis, Optune treatment median OS was cited at 19.6 months, whereas DCVax blended OS is cited on both JTM and SNO figures as 23.1 months. Advantage DCVax. Until you subtract the 3.1 months which was the DCVax median time from surgery to randomization, and you get 19.6 v 20.0 months.
And so the true advantage on median OS to DCVax is very small.
But of course the DCVax figures are blended. And the advantage could be significantly bigger when we are talking about DCVax treatment only, after unblinding.
But I've never said anything otherwise.
I've said on several occasions that the Optune treatment and DCVax blended stats are neck and neck, until the DCVax long tail survival kicks in.
Reason enough to continue the trial until the long term survival advantage to DCVax over Optune turns from being a projected one to an actual one.
The Optune figures are also confounding because they have their interim figures which supported the approval (or label extension) and their final figures. And the final figures are a lot worse than their interim figures.
And then you have their two sets of figures, ITT and Per Protocol.
And then you have their website quoted figures that don't appear to tally with their official figures as submitted to the FDA!
The idea of measuring from surgery is not 'ridiculous'.
It's just that in making cross trial comparisons, you have to be aware of which trial is using which clock start, and adjust accordingly.
I don't believe DCVax is out of step with everybody else. I think there are other trials that also used diagnosis or surgery as the starting gun.
It would require someone with the time on their hands to look at other significant trials in the ndGBM space to check this out.
I guess these would include Stupp 2005, Brandes, maybe Rintega and one or two others for a full comparison.
But none of the past ndGBM P3's that I'm aware of, have better figures than what we are seeing in the DCVax trial.
And yes they all have slightly different inclusion/exclusion criteria, so any comparison will be imperfect anyway!
Surely you are making my point here. The longer the gap between surgery and randomization, the more early progressors you exclude.
Optune had the longest gap of any trial I am aware of.
Recent NWBO News
- Form NT 10-K - Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405 • Edgar (US Regulatory) • 03/01/2024 10:04:38 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/02/2023 01:31:35 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/16/2023 10:11:54 PM
- Epazz, Inc. (OTC Pink: EPAZ) ZenaDrone Demonstration to Defense Departments of UAE and Saudi Arabia • InvestorsHub NewsWire • 11/15/2023 12:19:31 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/09/2023 09:30:39 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration ZenaDrone 1000 • InvestorsHub NewsWire • 11/09/2023 01:00:34 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration ZenaDrone 1000 Extreme Weather Demo • InvestorsHub NewsWire • 11/07/2023 12:29:43 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2023 08:36:14 PM
FEATURED Glucotrack Announces Expansion of Its Continuous Glucose Monitoring Technology to Epidural Glucose Monitoring • Apr 17, 2024 8:00 AM
ILUS Provides Form 10-K Filing Update • ILUS • Apr 17, 2024 9:54 AM
Maybacks Global Entertainment To Fire Up 24 New Stations in Louisiana • AHRO • Apr 16, 2024 1:30 PM
Cannabix Technologies Begins Certification of Contactless Alcohol Breathalyzer, Re-Brands product series to Breath Logix • BLOZF • Apr 16, 2024 8:52 AM
Kona Gold Beverages, Inc. Acquires Surge Distribution LLC from Loud Beverage Group, Inc. (LBEV) • KGKG • Apr 16, 2024 8:30 AM
Branded Legacy, Inc. Reports Significant Net Income of Over $3.8 Million • BLEG • Apr 16, 2024 8:30 AM