How Sponsors Could Gain Advantage by Embracing Dose Optimisation in Asia by 2026

In 2026, oncology drug development in Asia may move away from the historical maximum tolerated dose (MTD) paradigm toward evidence-based dose optimisation. Sponsors might consider adopting strategies similar to the FDA's Project Optimus, which emphasises selecting doses that balance efficacy and safety rather than relying solely on toxicity thresholds. Doing so could improve patient outcomes and position companies favourably as regulatory expectations evolve.

- By Pascal Piedbois, Chief Medical Officer, One2Treat, France

Early-phase oncology trials have traditionally focused on identifying the MTD, assuming higher doses produced greater efficacy. While this approach was appropriate for cytotoxic chemotherapies, it is increasingly unsuitable for targeted therapies and immuno-oncology agents, where efficacy often plateaus below the MTD and toxicity rises unnecessarily. Excessive dosing can lead to avoidable adverse events, dose interruptions, and discontinuations, reducing patient benefit and increasing healthcare burden.

Why Sponsors Should Act Now