Faster FDA Review A Possibility For Celldex’s Rintega After Phase II
This article was originally published in The Pink Sheet Daily
Executive Summary
Celldex presented positive data from a Phase II study testing the therapeutic cancer vaccine Rintega in patients with EGFRvIII-positive recurrent glioblastoma, including a survival advantage, at ASCO.
You may also be interested in...
Celldex At A Loss To Explain Why Brain Cancer Vaccine Rintega Failed Phase III
Rintega performed as usual in Phase III ACT IV study, but comparator arm Temodar was much better than in prior trials, for unknown reasons.
Celldex Couldn’t Sway FDA On Rintega
Although it yielded impressive survival data compared to standard of care, the Phase II ReACT study was not powered for efficacy, so FDA is requiring Phase III data as well despite the need in glioblastoma.
Opdivo/Yervoy Data Show Role For Checkpoint Combos; ASCO Debates Biomarkers
In Bristol’s CheckMate 067, PD-1 monotherapy performs as well as the PD-1/CTLA-4 combination in melanoma patients with higher expression of the PD-L1 biomarker, a finding that implies a personalized immunotherapy approach in the future.