OlympiA
Adjuvant olaparib versus placebo in patients with germline BRCA1 or BRCA2 pathogenic variants and high-risk HER2-negative early breast cancer
Phase 3N = 1,836NCT02032823
- Population
- HER2-negative high-risk early breast cancer with germline BRCA1 or BRCA2 pathogenic or likely pathogenic variants
- Design
- Double-blind, randomised 1:1 phase 3 trial of one year of oral olaparib versus placebo after local treatment and neoadjuvant or adjuvant chemotherapy. Endocrine therapy was given concurrently for hormone receptor-positive cancers.
- Primary endpoint
- iDFS
- Arms
- Olaparib (experimental): One year of oral olaparib
- Placebo (control): One year of placebo
- People
- Tutt ANJ, OlympiA Clinical Trial Steering Committee and Investigators
iDFSHR 0.58Δ 36-month iDFS+8.8 pointsOSHR 0.68OSHR 0.68Δ 48-month OS+3.4 pointsΔ 48-month iDFS+7.3 points
Show the numbers
| Endpoint | Analysis | Olaparib | Placebo | Effect |
|---|---|---|---|---|
| iDFS | interimmedian follow-up 2.5 yearsTutt 2021 | 85.9% at 3 y | 77.1% at 3 y | HR 0.58P<0.001Difference 8.8 percentage points (95% CI 4.5 to 13.0). Hazard ratio for invasive disease or death 0.58 with a 99.5% CI of 0.41 to 0.82 (published interval is not a 95% CI). |
| OS | interimmedian follow-up 2.5 yearsTutt 2021 | — | — | HR 0.68P=0.02Deaths: 59 with olaparib and 86 with placebo. Hazard ratio for death 0.68 with a 99% CI of 0.44 to 1.05. The difference did not meet the interim-analysis boundary of P less than 0.01. |
| OS | interimmedian follow-up 3.5 yearsGeyer 2022 | 89.8% at 4 y | 86.4% at 4 y | HR 0.68P=0.009Hazard ratio for death 0.68 with a 98.5% CI of 0.47 to 0.97. Significance for OS at this analysis required P < 0.015. Four-year difference 3.4% (95% CI -0.1% to 6.8%). |
| iDFS | interimmedian follow-up 3.5 yearsGeyer 2022 | 82.7% at 4 y | 75.4% at 4 y | Difference 7.3% (95% CI 3.0% to 11.5%). |
| Endpoint | Analysis | Olaparib | Placebo | Effect |
|---|---|---|---|---|
| iDFS | interimmedian follow-up 2.5 yearsTutt 2021 | 85.9% at 3 y | 77.1% at 3 y | HR 0.58P<0.001Difference 8.8 percentage points (95% CI 4.5 to 13.0). Hazard ratio for invasive disease or death 0.58 with a 99.5% CI of 0.41 to 0.82 (published interval is not a 95% CI). |
| OS | interimmedian follow-up 2.5 yearsTutt 2021 | — | — | HR 0.68P=0.02Deaths: 59 with olaparib and 86 with placebo. Hazard ratio for death 0.68 with a 99% CI of 0.44 to 1.05. The difference did not meet the interim-analysis boundary of P less than 0.01. |
| OS | interimmedian follow-up 3.5 yearsGeyer 2022 | 89.8% at 4 y | 86.4% at 4 y | HR 0.68P=0.009Hazard ratio for death 0.68 with a 98.5% CI of 0.47 to 0.97. Significance for OS at this analysis required P < 0.015. Four-year difference 3.4% (95% CI -0.1% to 6.8%). |
| iDFS | interimmedian follow-up 3.5 yearsGeyer 2022 | 82.7% at 4 y | 75.4% at 4 y | Difference 7.3% (95% CI 3.0% to 11.5%). |
Appears in
Sources
Tutt ANJ, Garber JE, Kaufman B, Viale G, Fumagalli D, Rastogi P, et al. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. N Engl J Med. 2021;384(25):2394-2405.
Geyer CE Jr, Garber JE, Gelber RD, Yothers G, Taboada M, Ross L, et al. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer. Ann Oncol. 2022;33(12):1250-1268.