All Times EDT
Keywords: combination therapy, contribution of components, real world data
Clinical trial designs for combination therapy development in Oncology are becoming exceedingly challenging. New combination therapies are likely to have a PD-(L)1 inhibitor as the backbone and patient populations in later lines of therapy are likely to have been exposed and are PD-(L)1 refractory. Additionally, in cold-tumors where existing data on PD(L)1 therapy is not impressive, single-agent PD(L)1 investigation is not viable or ethical. Thus, trial design, choice of appropriate treatment groups, demonstration of contribution of components, borrowing information from existing data on the PD(l)1 class and usage of real world data, need to be carefully considered in design and analysis. The statistical challenges in oncology combination development and possible solutions will be illustrated through some examples in solid tumors