The first-in-human immuno-oncology problem

It’s becoming increasingly difficult to achieve tumor shrinkage in Phase I trials of targeted immuno-oncology therapies, and that’s putting companies in a difficult position, as it’s often not clear how to make go/no-go decisions based on small, first-in-human datasets.

A large part of the “problem” is not really a problem at all. The success of the first wave of PD-(L)1 checkpoint inhibitors has led the products to become integrated into standard of care (SOC) across most solid tumor indications. This in turn has meant that patients enrolling in Phase I studies tend to have more refractory disease than a decade ago, given that their tumors have advanced after treatment with checkpoint inhibitors and multiple other lines of therapy...