Project Optimus is an FDA initiative aimed at improving dose optimization in oncology by identifying treatments that maximize efficacy while minimizing toxicity.
One2Treat Insights is a quantitative benefit-risk platform that integrates efficacy, safety, and tolerability outcomes to support data-driven dose optimization aligned with Project Optimus expectations.
Make better dose decisions using the totality of the evidence
- Inform dose optimization for FDA’s Project Optimus by evaluating efficacy, safety, and tolerability together
- Identify optimal dose levels that balance clinical benefit and risk, rather than relying on maximum tolerated dose approaches
- Strengthen regulatory and internal decision-making with transparent, quantitative evidence
- Support early signal detection and pivotal trial design with a consistent, data-driven methodology
FDA’s Project Optimus requires sponsors to move beyond traditional dose selection strategies and demonstrate that selected doses provide the best balance between efficacy and safety. This shift emphasizes the use of comprehensive clinical evidence, including dose-response relationships and patient-reported outcomes, to support dose justification.
One2Treat Insights enables this approach by integrating the totality of the evidence into a unified analysis framework, allowing teams to quantify treatment value at each dose level and select strategies that align with both regulatory expectations and clinical objectives.
Whether you are exploring early dose signals or preparing for regulatory discussions, One2Treat Insights provides the clarity needed to move forward with confidence.
