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survivor1x

02/01/19 2:50 PM

#211768 RE: photonic5 #211450

Yeah, they will have exact survival data >than 3 years for all comers. They will also likely have MOA and other informational data that helps explain why others lived so long. Like before and afters of CD4/CD8, pd-1 expression, cytokines, TNF or imaging like this

https://www.cell.com/trends/cancer/fulltext/S2405-8033(18)30080-3


"The rapidly evolving field of cancer immunotherapy recently saw the approval of several new therapeutic antibodies. Several cell therapies, for example, chimeric antigen receptor-expressing T cells (CAR-T), are currently in clinical trials for a variety of cancers and other diseases. However, approaches to monitor changes in the immune status of tumors or to predict therapeutic responses are limited. Monitoring lymphocytes from whole blood or biopsies does not provide dynamic and spatial information about T cells in heterogeneous tumors. Positron emission tomography (PET) imaging using probes specific for T cells can noninvasively monitor systemic and intratumoral immune alterations during experimental therapies and may have an important and expanding value in the clinic. "
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exwannabe

02/01/19 3:00 PM

#211771 RE: photonic5 #211450

But survival data is gonna be undeniable.


If so, why has Les put crossover in play as an issue with getting results?

Undeniable OS results would be ITT treatment arm vs placebo arm, regardless of crossover. Many trials have crossover, they report the data as randomized and the crossover effect is not more or less than all the other OS confoundments caused by various follow-up treatments.

So why is this an issue here? Perhaps the OS arms do not separate and Les want to start laying the groundwork for crossover being the issue? If so, the data will certainly be "deniable".