POLO
The first biomarker-directed drug approval in pancreatic cancer, for the roughly 5-7% with inherited BRCA mutations, though it did not extend overall survival.
154 patients. PFS 7.4 vs 3.8 months (HR 0.53); OS not different (19.0 vs 19.2 months). FDA approval December 2019. Made germline testing standard for every pancreatic cancer patient.
Setting
Germline BRCA-mutated metastatic PDAC not progressed on ≥16 weeks of platinum: olaparib maintenance vs placebo
Phase
Phase 3
Sponsor
AstraZeneca / Merck
Registry
Headline result
PFS HR 0.53; OS HR 0.83 (not significant).
Reported
2019
Enrolled
154
Replication
Single pivotal trial; PFS but not OS. No confirmatory trial.
In plain words
What these results mean for people, not percentages
Progression-free survivalprimarysurrogate endpoint
- Median 7.4 vs 3.8 months with Olaparib maintenance compared with Placebo; about 3.6 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 47 percent lower chance of the event at any given time (hazard ratio 0.53, likely range 0.35 to 0.82).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
Overall survivalsurvival endpoint
- Median 19 vs 19.2 months with Olaparib maintenance compared with Placebo; about 0.2 months shorter for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 17 percent lower chance of the event at any given time (hazard ratio 0.83).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- Not significant.
Be careful
- These results apply to the people the trial enrolled: Germline BRCA-mutated metastatic PDAC not progressed on ≥16 weeks of platinum: olaparib maintenance vs placebo. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (BRCA); the result should not be assumed for people whose cancer does not have it.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
154 participants enrolled.
Progression-free survivalprimary
HR 0.53 (0.35–0.82) · p = 0.004
Olaparib maintenance
7.4 mo
Placebo
3.8 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Olaparib maintenance | 92 | 7.4 months | 0.53 (0.35–0.82) | 0.004 | link |
| Placebo | 62 | 3.8 months | ||||
| Overall survival | Olaparib maintenance | — | 19 months | 0.83 | — | link |
| Placebo | — | 19.2 months |
Replication
Single pivotal trial; PFS but not OS. No confirmatory trial.