FDA analysis correlates ORR with PFS in lung cancer

A meta-analysis published Monday in the Journal of Clinical Oncology showed higher objective response rates (ORR) were associated with improved progression free survival (PFS) in patients with advanced non-small cell lung cancer (NSCLC), suggesting ORR may be a useful surrogate endpoint for PFS.

A group of FDA researchers led by Gideon Blumenthal analyzed 14 trials conducted from 2003-13. The researchers found a strong association between ORR and PFS at the trial level. Blumenthal told BioCentury the data suggest that a robust ORR may predict a large gain in PFS in NSCLC trials. He said the association could be particularly useful when evaluating targeted therapies in small trials not powered to assess OS. ...