no statistical significance. OS 12.0 months 7.9 months HR = .43 (0.13, 1.44) ; p=0.16
PFS 3.7 months 2.0 months HR= .74 (0.34, 1.61); p=0.47
Sentiment: Strong Sell
Hey, psst, #$%$-weed, P values you morn has NADA bearing, NO bearing at this level of trial results. If the results OS and PFS which were impressive to outstanding remains (as is fully anticipated) those P values (per larger trial size/enrollement) will change in accordance. You #$%$head moron, Get lost!
PV values are better extraplotated in larger trials, I do believe in their meaning but in Cancer its about overall survival, and PFS and in todays market are we seeing different and unique methods to address unmet needs that brings opportunity to others. Rindo continues to demonstrate its consistency and will probably be an early approval product.
Shorts Are FRIED !
Rindopepimut demonstrates ability to SiGNIFICANTLY shrink recurrent and refractory glioblastomas POST
Celldex Therapeutics' Rindopepimut Demonstrates Promising Clinical Activity in Patients with
EGFRvIIIpositive Recurrent Glioblastoma at SNO
HAMPTON, N.J., Nov 24, 2013 (Menafn - GLOBE NEWSWIRE via COMTEX) --Strong interim survival trend (12.0 vs 7.9 months) emerging in ongoing bevacizumab naive randomized cohort; 5.6 month median OS (48% 6 months) in bevacizumab refractory single-arm cohort; robust anti-tumor immune responses were generated among heavily pre-treated patients with recurrent tumors and these responses correlate with improved outcome
Rindopepimut demonstrates ability to significantly shrink recurrent and refractory glioblastomas
Long-term survival update also provided for three Phase 2 frontline studies; EGFRvIII patients continue to exceed expectations with 14% 5-year survival vs 0% historical control
Celldex Therapeutics, Inc. CLDX today reported interim data from its ongoing, exploratory Phase 2 ReACT study of rindopepimut in recurrent glioblastoma. Rindopepimut is an immunotherapeutic vaccine that targets the tumor specific oncogene EGFRvIII(v3). Patients with EGFRvIII-positive glioblastoma typically have a worse prognosis than the overall glioblastoma population, including poor long term survival. The ReACT results demonstrate promising signs of clinical activity in advanced patient populations, including patients both nave and refractory to bevacizumab (Avastin). An update on long-term survival for the three completed Phase 2 frontline studies in EGFRvIII-positive glioblastoma was also presented and results continue to exceed outcomes seen in contemporary controls. A webcast/conference call will be held at 8:30 am ET on Monday, November 25
For the 13 patients with high titers by day 57, median OS was 6.6 months versus 3.2 months for the 11 patients who did not develop high titers (HR = .33 (0.08, 0.67); p=0.009).
So let's see dear brilliant one! OS of 6.6 versus 3.2. Let alone, you want to go head to head you moron, the elimination of EGFRvIII saw a 400% increase in comparison in frontline Rindo, thus increasing the ability for Avastin (or rather the synergistic action between Rindo/Avastin) to be extremely impressive. Not seen before.