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scotty3371

05/11/22 6:24 AM

#470766 RE: dmb2 #470763

LL said a majority of the top 100 were pfs at 3 years. What was that number?

About 46/55 from treatment group; 31 went on to live 5 years.






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exwannabe

05/11/22 12:19 PM

#471102 RE: dmb2 #470763

The 1 piece of data that is perplexing is the 20% survival at 3 yrs for the 232 treated population, which I expected to be higher, given the previously reported blended 28%


There is no deep analysis needed. The blended population lived as long or longer than the treatment arm. In short, those who were randomized to placebo drew the lucky straw.

I agree on the surprise on the result against significant residual disease after NWBO disclosing tumor debulking was an important factor, but the difference between levels of resection can be dramatic and there is no quantification here. So this result is actually good news.


This is important, but you have to look at what it is saying.

For the MRD population (patients for whom most all tumor has been removed) DCVAx-L made little to no difference in OS. It was in patients for whom a significant amount of tumor was left where DCVax-L shined.

But, as you say, that is not a monolithic group. It has a broad range, The DC P3 trial had an inclusion criterion of "intent for near total resection". The ECA did not. The P3 will have almost all patients with little tumor left, even if over 2 cm^2 contrast it will not be a lot. The ECA will have patients with significantly more residue burden.

Extent of resection really matters. And "intent for near total" will leave less than partials.
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Doc logic

05/11/22 2:52 PM

#471265 RE: dmb2 #470763

dmb2,

Right. There was 20% 3 year survival for treatment vs 8% survival in SOC/placebo including a 3:1 survival benefit to that point for those that crossed over compared to those who did not based on the 2018 numbers with the 2022 unblinded data for treatment patients plugged in. In real numbers that’s 20% of 232 or roughly 47 patients vs 8% of 331 or roughly 27+1 for powering discrepancy from missing 17 SOC/placebo patients, where 6 of those 36 month survivors were crossover patients and 22 were not. By removing the crossover patient benefit noted elsewhere in the data by removing these 6 from the analysis to consider separately you have 22 SOC/placebo vs 47 DCVAX(R)-L treatment living 36 months or more. This is approximately where the long term advantage from DCVAX(R)-L begins per previous analysis by NWBO; ). Best wishes.