There is much excitement in the field of immuno-oncology drugs with the approval of sipuleucel-T (Provenge), ipilimumab (Yervoy), and the very promising data on other checkpoint modulators, new oncolytic viruses, and therapeutic vaccines on the horizon. There are some important adjustments in treatment response criteria, endpoints, and trial design that need to be made to maximize the demonstration of the clinical advantages of this new class of drugs. The chief reason for the need for this readjustment is the difference in the response pattern between…
Jeffrey Weisberg, DO, FACP, Vice President, Medical Affairs, Oncology, Worldwide Clinical Trials. Worldwide Clinical Trials provides full-service drug development services to the pharmaceutical and biotechnology industries from early phase and bioanalytical sciences through Phase II and III trials to peri-approval. For more information, visit wwctrials.com.