142: Landscape Analysis of Dose Optimization Approaches in Oncology Investigational New Drug (IND) Submissions in 2023

Statement of Purpose, Innovation or Hypothesis: In this research, we conducted a landscape analysis of oncology Investigational New Drug (IND) submissions and the Model-Informed Drug Development (MIDD) Paired Meeting Program in 2023. We summarized the dose-finding designs in phase I trials, the pharmacodynamic (PD) biomarkers involved in dose optimization, and the MIDD approaches for dose determination, with the goal of providing a landscape of dose optimization methods in recent oncology IND submissions.

Description of Methods & Materials: This analysis was performed by searching an internal database from the Center for Drug Evaluation and Research (CDER) for oncology INDs related to dose finding from Jan.1, 2023 to Aug. 31, 2023. We evaluated 76 INDs which fit the search criteria. We also searched the internal MIDD Paired Meeting Program database for the IND submissions that have oncology indications in 2023.

Data & Results: From our analysis, the adoption of more sophisticated and precise clinical trial design, involvement of pharmacogenomic (PGx) and PD biomarkers, application of MIDD approaches, and close two-way engagement between FDA and industry are crucial for successful oncology drug development program. With joint efforts from FDA and industry, oncology patients can receive therapies that maximize efficacy while minimizing toxicity.

Interpretation, Conclusion or Significance:

Disclosures: The contents of this article reflect the views of the authors and should not be construed to represent the FDA’s views or policies. No official support or endorsement by the FDA is intended or should be inferred.

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Additional Information/Authors: N/A