Measuring response30 Nov 2022 14:29
Found this on the Farn site interesting. It's related to their trial but of interest re Scancell??
The inclusion of irORR seems logical as these newer immunotherapy treatments can have slightly different observable results compared to more standard treatments .
From searching internet - this new method allows for differing time scales on efficacy ( ie small immediate improvement - but leads to bigger long term one ( ie extended life) , and in some cases the tumour size may even increase before reducing .
So looks like FDA have allowed them to adopt the more modern response measurement techniques.
To evaluate antitumor responses to chemotherapeutic agents, investigators would typically rely upon Response Evaluation Criteria in Solid Tumors (RECIST) or modified WHO criteria, which do not comprehensively capture responses with immunotherapeutic agents. In the December 1, 2009, issue of Clinical Cancer Research, Wolchok and colleagues reported their development of novel criteria, designated “Immune-related Response Criteria” (irRC), designed to better capture the response patterns observed with immunotherapies. Broad use of the irRC since then has allowed for a more comprehensive evaluation of immunotherapies in clinical trials, indicating that their concepts can be used in conjunction with either RECIST or WHO, and has shown irRC to be a powerful tool for improved clinical investigation.