POLO

NCT02184195 📎

Regimen

Experimental
Olaparib tablets 300 mg PO BID continuous maintenance until progression
Control
Matched placebo tablets BID continuous until progression

Population

Metastatic PDAC with deleterious/suspected deleterious germline BRCA1 or BRCA2 mutation (~4-7% of PDAC), disease not progressed after ≥16 weeks of 1L platinum-based chemotherapy. Olaparib n=92, placebo n=62. Global (12 countries).

Key finding

First positive biomarker-selected phase 3 in PDAC: significant PFS improvement (HR 0.53) led to FDA approval (Dec 2019) of olaparib maintenance for gBRCA+ metastatic PDAC — the first molecularly-targeted therapy approved in PDAC. Final OS null (HR 0.83, p=0.35) despite numerical direction favoring olaparib. Long-term survivor subset and extended chemo-free interval remain clinical benefits.

Source: PMID 35834777

Timeline

    Guideline citations

    • NCCN PANCREATIC (p.101)