Three Insights For Immuno-oncology Drug Discovery

Insight No. 1 is from John Carroll's Endpoints News coverage of the Cancer Research Institute's (CRI) latest "landscape" analysis in the December 2017 Annals of Oncology. There are 2,004 immuno-oncology agents crowding the pipeline, as inventoried in the graphic below. Just in 2017, for example, 469 new PD-1/L1 oncology studies were launched, requiring 52,000 patients to fully enroll them. There are already 164 PD-1/L1 drugs in the works, 50 in the clinic and 5 on the market. These alone have generated  over 1,500 trials, before adding in the development burden of 344 cancer vaccines and 224 clinical-stage cell therapies.

The sobering realization from reading these reports is that fanfare surrounding cancer immunotherapy presages an inevitable bust after such a boom. Blame the vagaries of clinical pharmacology, especially the requirements for PK/PD and what is rapidly becoming a structural inability to enroll enough patients. More numbers per trial will be needed to establish at a minimum a dose-response relationship, as well as a broad enough therapeutic index to guarantee safety. And the reality is that there aren't enough patients to go around.