What Can Healthy Participants Tell Us In Early Immuno-oncology Development?

First-in-human oncology studies have traditionally enrolled patients, and for many compounds that remains the right call. But as more therapies act on defined, measurable immune pathways, the question of who can answer the earliest pharmacology questions deserves a closer look.

This sixth installment in the series What Early Human Data Tells Us weighs the case for healthy participants against its real limits. It draws on a systematic review of 38 immunotherapeutic compounds previously tested in healthy people, and on a CHDR study that sampled blood and bone marrow after a controlled immune challenge. It also sets out three conditions that make the approach most compelling, and is candid about where patient-first development still wins.

Explore the evidence and judge where it fits your programme.