ARTICLE | Regulation
Searching for I-O surrogates
How new endpoint from FDA might provide a surrogate for immuno-oncology trials
October 24, 2016 7:00 AM UTC
FDA’s development of an intermediate endpoint for immuno-oncology trials could provide a new surrogate that correlates better with overall survival than ORR or PFS as measured by RECIST criteria.
FDA has tested the new endpoint, called intermediate endpoint, or IME, using a data set from 5,806 patients in nine clinical trials of anti-PD-1 mAbs, all of which had OS as a primary or co-primary endpoint. ...