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PAOLA-1 / ENGOT-ov25

Adding olaparib to bevacizumab maintenance roughly doubled progression-free time in tumours with faulty DNA repair, and improved survival in that group.

PFS 22.1 vs 16.6 months overall (HR 0.59) and 37.2 vs 17.7 months in HRD-positive tumours (HR 0.33; NEJM 2019). Five-year OS in HRD-positive patients was 65.5% vs 48.4% (HR 0.62; Annals of Oncology 2023). No benefit in HRD-negative disease. Approved in 2020 for HRD-positive tumours; it established HRD testing as a decision point.

Setting
Newly diagnosed advanced ovarian cancer already on bevacizumab maintenance: adding olaparib vs placebo
Phase
Phase 3
Sponsor
ARCAGY-GINECO / AstraZeneca
Registry
Headline result
PFS HR 0.59 overall, 0.33 HRD-positive; 5-year OS 65.5% vs 48.4% in HRD-positive.
Reported
2019
Enrolled
806

Outcomes

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In plain words
What these results mean for people, not percentages
806 people took part
Progression-free survival (HRD-positive)surrogate endpoint
  • Median 37.2 vs 17.7 months with Olaparib + bevacizumab compared with Placebo + bevacizumab; about 19.5 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 67 percent lower chance of the event at any given time (hazard ratio 0.33, likely range 0.25 to 0.45).
  • 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 5 years (HRD-positive)survival endpoint
  • 65.5 vs 48.4 out of 100 alive at 5 years with Olaparib + bevacizumab compared with Placebo + bevacizumab; 17.1 more per 100.
  • Roughly one extra person helped for every 6 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 38 percent lower chance of the event at any given time (hazard ratio 0.62, likely range 0.45 to 0.85).
  • 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: Newly diagnosed advanced ovarian cancer already on bevacizumab maintenance: adding olaparib vs placebo. People in a different situation may not see the same effect.

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.

806 participants enrolled.

Progression-free survival (HRD-positive)
HR 0.33 (0.25–0.45)
Olaparib + bevacizumab
37.2 mo
Placebo + bevacizumab
17.7 mo
Source
Overall survival at 5 years (HRD-positive)
HR 0.62 (0.45–0.85)
Olaparib + bevacizumab65.5 of 100
Placebo + bevacizumab48.4 of 100
Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survival (HRD-positive)Olaparib + bevacizumab37.2 months0.33 (0.25–0.45)link
Placebo + bevacizumab17.7 months
Overall survival at 5 years (HRD-positive)Olaparib + bevacizumab65.5%0.62 (0.45–0.85)link
Placebo + bevacizumab48.4%

Connected

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