IO Bio Plans Cancer Vaccine Filing Despite Trial Miss
IO Biotech aims for FDA approval despite narrowly missing progression-free survival endpoint, citing stronger benefits in untreated subgroups and a 23% relative risk reduction, company said.
6 Articles
6 Articles
IO Biotech to pursue cancer vaccine approval despite Phase III miss
The cancer vaccine did not significantly boost progression-free survival (PFS), but IO Biotech plans to seek out its approval anyway.The post IO Biotech to pursue cancer vaccine approval despite Phase III miss appeared first on Clinical Trials Arena.
IO Biotech to seek FDA filing even though cancer vaccine narrowly fails pivotal skin cancer study
IO Biotech's late-stage trial of its cancer vaccine, added to Merck's Keytruda in melanoma, narrowly missed its primary endpoint, but it plans to emphasize subgroups and safety as it heads to the FDA to ask ...
IO Biotech’s cancer jab falls short in Phase 3, but Danish firm still eyes FDA approval - European Biotechnology Magazine
IO Biotech has published top-line results from its pivotal Phase 3 trial evaluating the therapeutic cancer vaccine IO102-IO103 (Cylembio) in combination with pembrolizumab in patients with advanced melanoma. While the combination achieved a notable improvement in progression-free survival (PFS), the study narrowly missed its predefined statistical threshold for significance. The post IO Biotech’s cancer jab falls short in Phase 3, but Danish fir…
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