What is Project Optimus?
Project Optimus, an initiative from the FDA, seeks to optimize dosing. Since the released draft guidance in 2023, early phase oncology drug development has shifted to accommodate. As an oncology specialist with significant early phase experience, Catalyst Oncology can help ensure your development plan is Project Optimus ready. 1, 2
What is the effect of Project Optimus?
Oncology clinical development has historically focused Phase I trials around the goal of determining a maximum tolerated dose (MTD). With the industry moving past chemotherapy to the advancement of targeted therapies and immuno-therapies, an MTD may not be as relevant. The guidance asks cancer drug developers to build dose optimization into their clinical development plans early and to balance efficacy and tolerability with a focus on real-world impacts and the patient experience.
Catalyst Observations of Project Optimus Impacts
Increased importance of early FDA interactions
Adaptive designs (BOIN is most popular; 3+3 is non-compliant)
Larger escalation sample sizes (50-60 patients including backfills)
Randomization against two dose levels in expansion
Increased interim analyses to enhance understanding of dosing
Incorporation of PK/PD data into cohort management decisions
Global footprint for wider patient access as early as first-in-human
How Catalyst Oncology can help:
Optimus GAP Analysis assessment
Clinical development plans
Phase I/II trial protocol design
Phase I/II trial delivery expertise, >75% of oncology pipeline
Global footprint: 1000+ staff across NA/EU/APAC
Bioanalytical analysis, PK modeling, simulation, and analyses
Partnerships for eCOA and DEI
1 – https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus
2 – https://www.fda.gov/regulatory-information/search-fda-guidance-documents/optimizing-dosage-human-prescription-drugs-and-biological-products-treatment-oncologic-diseases
