dose immuno-oncology IO

Challenges and Opportunities in Dose Finding in Oncology and Immuno-oncology

by Yan Ji, Jin Y. Jin, David M. Hyman, Geoffrey Kim and Ajit Suri

Jul 11^th 2018
10 mins
Clincal and Translational Science

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Summary

Focus on optimizing oncology therapeutics through quantitative translational and clinical pharmacology.
Emphasis on dosage precision to maximize patient benefit.
Challenges include confounding factors in exposure-response (ER) analysis, particularly for biologics.
Necessity for multifaceted modeling to account for biases in ER analysis.
Encouragement of novel trial designs and advanced modeling and simulation (M&S) methods for better dose selection.
Studies show M&S in phases II/III can inform dosing and efficacy, as seen with atezolizumab.
Collaboration across scientific disciplines is crucial for addressing challenges in cancer therapies.
ER analysis aids in dose justification and optimization, though some cases may require postmarketing trials for refinement.
Innovative design and analytical approaches using various data sources can enhance anticancer therapy optimization.

Today's cancer therapy has made substantial progress. Recent success in immuno‐oncology (IO) and combination therapies provide opportunities to enhance activity in the broader population with less drug resistance. However, these advances also raise challenges in oncology drug development. At the 2017 American Society of Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting, these issues were addressed in a symposium with case studies illustrating challenges and opportunities. The presentations and discussion are summarized in this review.

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dose, immuno-oncology, IO