About this document
Sintilimab ODAC Meeting Insights by raulwang2015 is a document available to read on EtoBox.
The FDA presentation discussed a clinical trial of sintilimab for nonsquamous non-small cell lung cancer conducted exclusively in China. The trial showed statistically significant improvement in progression-free survival but did not formally test overall survival. The FDA raised key issues with generalizing the trial results to the US population due to differences in standard of care and the substandard chemotherapy comparator arm used in the trial.
- Author
- raulwang2015
- Language
- EN