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An unprecedented number of new cancer targets are in development, and mostare being developed in combination therapies. Early oncology development isstrategically challenged in choosing the best combinations to move forward tolate stage development. The most common early endpoints to be assessed in suchdecision-making include objective response rate, duration of response and tumorsize change. In this paper, using independent-drug-action andBliss-drug-independence concepts as a foundation, we introduce simple models topredict combination therapy efficacy for duration of response and tumor sizechange. These models complement previous publications using the independentaction models (Palmer 2017, Schmidt 2020) to predict progression-free survivaland objective response rate and serve as new predictive models to understanddrug combinations for early endpoints. The models can be applied to predict thecombination treatment effect for early endpoints given monotherapy data, or toestimate the possible effect of one monotherapy in the combination if data areavailable from the combination therapy and the other monotherapy. Suchquantitative work facilitates efficient oncology drug development.

Independent Action Models and Prediction of Combination Treatment  Effects for Response Rate, Duration of Response and Tumor Size Change in  Oncology Drug Development