168P Analysis of endpoints used for FDA approvals of checkpoint inhibitors

ConclusionRR and DOR were the most frequently approved surrogate endpoints, most often for use in later lines of therapy. The majority of CPI approvals need to confirm the real impact on the patients ’ survival, since approximately one third of these approvals were based on the OS. Accelerated approvals based on surrogate endpoints were also preferentially granted for later lines of therapy, where such decisions may have a modest impact on the patients’ survival.Legal entity responsible for the studyThe authors.FundingHas not received any funding.DisclosureThe author has declared no conflicts of interest.
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research