Page 22 - Flipbook

TOPARP: An investigator-initiated trial for mCRPC

• Multi-stage, adaptive, trial for predictive biomarker qualification

Study objectives:

➢To evaluate anti-tumor activity of olaparib

➢To clinically qualify predictive biomarkers of PARPi response

➢Test set : No molecular selection (TOPARP-A)

➢DDR gene alterations associated with response to olaparib (Mateo et al,

NEJM 2015); no durable PSA responses in tumours without DNA repair defects

➢Validation set: Molecularly selected (TOPARP-B)

Mateo et al, NEJM 2015 and Lancet Oncology, 2020 22