The latest twist in the overall survival debate

Overall survival as the gold standard of cancer endpoints is a topic of debate yet again. But this time it’s a little different, as there are clear signs of greater regulatory flexibility on the important but controversial metric.

Overall survival (OS) stands apart from other cancer endpoints as a composite measure of both safety and efficacy, as a drug’s therapeutic benefit and adverse events can both impact mortality. In a world free of confounding variables, OS would provide a definitive measure of the long-term net effect of therapeutic activity and side effects...