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IL-12 mOSASCO docs reveal 4 KM curves, but fail to aggregate the data into various mOS. It's not difficult to do so. Survival by Group and Veledimex Dose Cohort This is the original trial with an adult stereotactic 20mg cohort added later. This is where the 12.7 mOS comes from. n=38. Midpoint between 19th and 20th tick is mOS. ~8.4 months. Even excluding stereotactic arm puts mOS is the same area. Survival in 20mg Veledimex (Main Study and Expansion Substudy) This is segregating only those who got 20mg V. Unifocal (n=36; 9 alive); Multifocal (n=15; 4 alive) There is actually a typo in the data. It says 5 multifocal alive, but there are 11 ticks and the other KM curve also says 4 alive. Total = 51 so 26th tick is mOS. ~11.7 months Survival of Subjects with Unifocal vs. Multifocal Disease by Total Concurrent Dose This is where Cooper is pointing to the 16.2 months as a four month survival extension. Unifocal (n=36, so midpoint of 18th and 19th tick is mOS). 18th is ~11.7 and 19th is ~12.5, so ~12.1 months. Imagine going to the FDA and saying we can extend life by 4 months, but only if they are unifocal and don't use a lot of steroids after the surgery. Good luck getting any insurance company to pay for that. The KM curve doesn't include Multifocal for some reason, however the median survival is ~10.3 months from the chart for those patients. Without the ticks we can't really pin down the actual timing, but simple math would put it around 11.5 months for all 51 patients on 20mgV. Now let's go back to compare to the 10,30,40 group from the "Survival by Group and Veledimex Dose Cohort" data. n=16 and midpoint between 8th and 9th is ~7 months. So this is where everything falls apart for me. The next KM shows why. Survival of Group 1 with Unifocal Disease by Dose Cohort and Cumulative Steroid Dose n=27. 14th tick is mOS. Looks to be about 8.4 months. The entirety (n=6) of the 20mgV/<20mg steroid cohort survived longer than all but 3 of the other 21. What possible scientific rational could there be to justify why that is the sweet spot. For all patients who had low steroid use, why would the V difference lead to 10 month extended survival. Meanwhile the Opdivo trial fails to show survival data and significantly reduces IL-12 and ILNy levels which is the rational for why mono works. Trust data over people. |
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Msg # | Subject | Author | Recs | Date Posted |
113879 | Re: IL-12 mOS | pharmionphil | 4 | 5/30/2020 12:12:07 PM |
113883 | Re: IL-12 mOS | Ubmmg | 1 | 5/31/2020 12:11:14 PM |
113891 | Re: IL-12 mOS | luckijack | 0 | 6/1/2020 11:55:11 AM |