Combination therapies are reshaping oncology, but dose optimization is complex and critical for safety and efficacy. Historically guided by maximum tolerated dose, today’s novel agents require more precise, data-informed strategies. FDA’s Project Optimus pushes sponsors to evaluate multiple dose levels early, emphasizing benefit-risk balance. Key considerations include drug-drug interactions, biomarkers like ctDNA, trial design, global regulatory demands, and advanced modeling to guide decisions. Sponsors must integrate translational science, adaptive designs, and model-informed drug development. Partnering with experienced CROs like IQVIA accelerates optimized regimens that improve patient outcomes.

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