Genasense lessons

Companies designing cancer trials should take one lesson from last week's Oncologic Drugs Advisory Committee meeting: if overall survival is the primary endpoint, sponsors should not expect that showing progression-free survival as the secondary endpoint will get them an approvable drug if the primary endpoint fails.

This is so even though FDA has unambiguously stated that progression-free survival (PFS) is an appropriate endpoint that can support approval for some forms of cancer. But the chances of persuading the agency that clinical efficacy has been documented are much higher if PFS is selected as the primary endpoint and trials are powered to show overall survival as a secondary endpoint. ...