Biotech Values

[biomaven0]

Pazdur hates PFS as an endpoint, and so perhaps is reluctant to sign-off on an SPA that uses PFS as an endpoint. But all sarcoma trials that I am aware of use PFS as their primary endpoint.

My prediction - the company goes ahead with PFS as their primary endpoint, but without an SPA.

Note that OS sounds nice and straightforward, but in a condition like sarcoma where the majority of newly diagnosed patients survive 5 years and more, it's actually a very murky endpoint indeed. When people progress, they drop out of the trial and move on to other therapies or are lost to follow-up. So really it's not feasible as a primary endpoint here.

Peter