This insight brief explores modern strategies for optimizing dosing in oncology combination therapies, aligning scientific best practices with evolving regulatory expectations such as the FDA’s Project Optimus. It explains why the traditional maximum tolerated dose approach is often inadequate for targeted therapies and immuno-oncology agents that require long-term administration. The brief outlines advanced dose-escalation designs, physiologically based pharmacokinetic modeling, exposure–response analyses, and model-informed drug development to identify optimal biological doses. Real-world case examples, including nivolumab plus relatlimab, illustrate how adaptive trial designs and integrated data improve safety, efficacy, and development efficiency. The approach enables faster developmen

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