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hankmanhub

01/30/22 9:04 PM

#439807 RE: meirluc #439806

Meirluc, you posted:

I am not mourning the removal of this group from the trial because those patients would have diluted the survival advantage of the Treatment group vis a vis the Controls.



I am afraid that most silver linings come with a cloud.

If they remove the proneural group from the trial and thus improve the likelihood of approval, I am then also afraid that an eventual approval will also not include the proneural group on the label and thus possibly diminish the revenue potential for DCVAX-L which will not be to the liking of investors.
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flipper44

01/30/22 9:59 PM

#439813 RE: meirluc #439806

Data summarized from many studies show that only approximately 5.6% of primary glioblastoma are IDH1 mutant, while more than 76% of secondary glioblastomas carry the IDH1 mutation. https://www.frontiersin.org/articles/10.3389/fonc.2016.00016/full#h5



….mutations in one of the IDH genes are tightly linked with the Proneural phenotype and secondary glioblastomas. Virtually all tumors with IDH mutation are of the Proneural gene expression subtype. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4109985/

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sentiment_stocks

01/31/22 2:02 AM

#439821 RE: meirluc #439806

Unfortunately, they won’t be removing any of the IDH mutated from the DCVax-L trial data.

They won’t be able to remove it from the external control arm data because many trials did not test for that.