termsTerm

Surrogate endpoint

aka surrogate, surrogates, surrogate endpoints, surrogate marker, surrogate for survival, validated surrogate, intermediate endpoint, intermediate clinical endpoint, early endpoint, reasonably likely to predict clinical benefit, trial-level surrogacy, patient-level surrogacy, surrogacy

A measurement that stands in for what patients care about (living longer, feeling better) because it can be read sooner: tumour shrinkage, time until the cancer grows, disappearance of cancer at surgery, or undetectable residual disease. Useful, but not every surrogate reliably predicts survival.

Progression-free survival, objective response, pathological complete response, MRD negativity and metastasis-free survival are the main surrogates in oncology; accelerated approval is explicitly built on endpoints 'reasonably likely to predict' benefit. Surrogacy is validated at trial level by showing that treatment effects on the surrogate correlate with effects on survival across many trials, and this holds well for some (metastasis-free survival in prostate cancer, pCR in triple-negative breast cancer, MRD in myeloma) and poorly for others (response rate in many solid tumours, PFS in ovarian cancer after crossover). Drugs approved on surrogates that later fail confirmatory survival trials are the recurring cautionary tale.

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Accelerated approval Confirmatory trial Crossover in trials Minimal / molecular residual disease (MRD)Pathologic complete response (pCR)Primary, secondary and co-primary endpoints Progression-free survival (PFS)