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OlympiA

Showed that a year of a PARP inhibitor after standard treatment improves survival in women with inherited BRCA mutations.

iDFS HR 0.58; OS HR 0.72 at 6 years. ~80% of participants had TNBC. Makes germline testing a treatment decision for every TNBC patient.

Setting
Adjuvant olaparib for one year in germline BRCA-mutated, HER2-negative, high-risk early breast cancer
Phase
Phase 3
Sponsor
AstraZeneca / NRG / BIG
Registry
NCT02032823
Headline result
iDFS HR 0.58; OS HR 0.72.
Reported
2021
Enrolled
1836
Replication
Single pivotal adjuvant trial with a sustained OS benefit at 6 years; consistent with the metastatic-setting PFS benefit of olaparib (OlympiAD) and talazoparib (EMBRACA).

Outcomes

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In plain words
What these results mean for people, not percentages
1,836 people took part
Invasive disease-free survival at 3 yearsprimarysurrogate endpoint
  • 85.9 vs 77.1 out of 100 alive without the cancer coming back at 3 years with Olaparib compared with Placebo; 8.8 more per 100.
  • Roughly one extra person helped for every 11 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • Put another way, the treated group had about 42 percent lower chance of the event at any given time (hazard ratio 0.58, likely range 0.41 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 survival at 4 yearssurvival endpoint
  • 89.8 vs 86.4 out of 100 alive at 4 years with Olaparib compared with Placebo; 3.4 more per 100.
  • Roughly one extra person helped for every 29 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • Put another way, the treated group had about 32 percent lower chance of the event at any given time (hazard ratio 0.68, likely range 0.47 to 0.97).
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Overall survival at 6 yearssurvival endpoint
  • 87.5 vs 83.2 out of 100 alive at 6 years with Olaparib compared with Placebo; 4.3 more per 100.
  • Roughly one extra person helped for every 23 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • Put another way, the treated group had about 28 percent lower chance of the event at any given time (hazard ratio 0.72, likely range 0.56 to 0.93).
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Be careful
  • These results apply to the people the trial enrolled: Adjuvant olaparib for one year in germline BRCA-mutated, HER2-negative, high-risk early breast cancer. 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.

1,836 participants enrolled.

Invasive disease-free survival at 3 yearsprimary
HR 0.58 (0.41–0.82) · p <0.001
Olaparib85.9 of 100
n = 921
Placebo77.1 of 100
n = 915
Source
Overall survival at 4 years
HR 0.68 (0.47–0.97) · p = 0.009
Olaparib89.8 of 100
Placebo86.4 of 100
Source
Overall survival at 6 years
HR 0.72 (0.56–0.93)
Olaparib87.5 of 100
Placebo83.2 of 100
Source
EndpointArmnValueHR (95% CI)pSource
Invasive disease-free survival at 3 yearsprimaryOlaparib92185.9%0.58 (0.41–0.82)<0.001link
Placebo91577.1%
Overall survival at 4 yearsOlaparib—89.8%0.68 (0.47–0.97)0.009link
Placebo—86.4%
Overall survival at 6 yearsOlaparib—87.5%0.72 (0.56–0.93)—link
Placebo—83.2%
Replication
Single pivotal adjuvant trial with a sustained OS benefit at 6 years; consistent with the metastatic-setting PFS benefit of olaparib (OlympiAD) and talazoparib (EMBRACA).

Key papers

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rctNew England Journal of Medicine 2021changed practice
OlympiA: a year of olaparib after surgery for BRCA-mutated, high-risk early breast cancer

Everyone with HER2-negative early breast cancer that meets high-risk criteria should be offered germline BRCA testing, because a positive result now changes treatment: a year of olaparib after chemotherapy reduces relapse and death. It does not apply to low-risk tumours, HER2-positive disease, or somatic-only BRCA mutations.

Connected

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Pages like this

not linked directly; found by shared links

cancers

2
HR-positive / HER2-negative breast cancerTriple-negative breast cancer (TNBC)

targets

1
BRCA1 / BRCA2 (HRD)

drugs

1
ApprovedSmall-molecule PARP inhibitor
Olaparib · Lynparza

institutions

4
Breast Cancer TrialsBreast International Group (BIG)Guy's and St Thomas' NHS Foundation Trust / King's Health Partners Cancer CentreNRG Oncology

terms

1
Germline BRCA mutation (gBRCA)

pairings

1
Germline BRCA test → adjuvant PARP inhibitor

roadmaps

1
TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line

people

3
Andrew TuttCharles E. Geyer Jr.Judy E. Garber

bottlenecks

1
Inherited risk is mostly unidentified

key papers

1
OlympiA: a year of olaparib after surgery for BRCA-mutated, high-risk early breast cancer