Results: Among 109 patients with EGFR-amplified primary glioblastoma, 63 had EGFRvIII-positive tumors by immunohistochemistry or RT-PCR or both. The detection of EGFRvIII was not associated with inferior progression-free survival (PFS) (HR = 0.85, 95%CI 0.58-1.25, p = 0.418) or overall survival (OS) (HR = 0.99, 95%CI 0.67-1.47, p = 0.961).
Conclusions: EGFRvIII expression is not prognostic in patients with EGFR-amplified glioblastomas.
Consistent with results of Phase III trial that found no benefit targeting EGFRvIII with rindo in newly diagnosed GBM.
EGFR gene amplification and variant III (EGFRvIII) mutation in primary and recurrent glioblastoma. ASCO 2016
The new hires were doing their job of justifying a high price for an effective rindopepimut.
Moot point now.
As soon as the FDA announces they will be discounting clinical trials in the future and instead rely more on message board posts to determine efficacy then this stock will take off.
I still haven't figured out what you're getting at.
You think the patients had the same data as the DSMB?
You think the patients who learned they were not receiving rindopepimut were so happy they were getting the placebo injection they stopped tumors from recurring and lived longer than they would have otherwise?
Or are you just trolling for amusement? If so try to liven it up with more stuff like the "genetic bias towards placebo" and less copy and paste stuff.
"Why did they not point to these earlier results and continue to defend the efficacy of their drug?"
My guess is their understanding of statistics and the biology of glioblastoma differs than that of neshua202.
The most likely explanation is the expectations were too low for the control arm.
Sure, there is a very small chance good luck raised the control arm results to above those of Rintega, but it is much more likely that the small numbers of similar patients culled from the control arms similar trials did not adequately represent what the larger control arm here.
As is popular here, it was PROVEN with STATISTICAL SIGNIFICANCE that Rintega better than standard of care. Only difference here is was done with many more patients and therefore much more of a robust result.
Well, cdx301 helps expand stem cells in the bone marrow; Stemcentrx antibody knocks out stem cells important to tumor growth. So yes, both companies do use the name "stem cell" in their press releases.
Or did you mean same geographical area? CDX301 was developed before the name change by Immunex in Seattle. Stemcentrx is located in the California Bay Area. Same coast!