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Peer-reviewedCC BYAnnals of oncology : official journal of the European Society for Medical Oncology

Sustained benefit of adjuvant olaparib in women with germline BRCA1- and BRCA2- -associated high-risk HER2-negative early breast cancer: Updated results from the OlympiA phase III trial

  • J. E. Garber1
  • D. Cameron2
  • C. Campbell3
  • G. Yothers4,5
  • M. Taboada6
  • S. El-abed7
  • P. Rastogi4,8
  • R. McConnell9
  • A. Correa10
  • S. Delaloge11
  • W. T. Liu12
  • P. Sharma13
55 more authors
  • J. Bergh14
  • W. Janni15
  • J. Balmaña16
  • N. Loman17
  • T. Španić18,19
  • S. Friedman20
  • T. Freeman4,21
  • A. Armstrong22
  • L. Korde23
  • S. Im24
  • Y. Sagara25
  • G. Viale26
  • J. Bliss27
  • L. Gianni28,29
  • Ó. Jóhannsson30
  • G. Zoppoli31,32
  • E. Martinez De Dueñas33,34
  • F. Marmé35,36
  • L. Fein37
  • M. Arnedos38,39
  • J. Ford40
  • R. Schmutzler
  • S. Loibl
  • B. Linderholm
  • S. R. Lakhani
  • M. Gnant
  • K. Gelmon
  • S. M. Domchek
  • E. Senkus
  • A. Eisen
  • A. Jager
  • M. Piccart
  • KA. Phillips
  • T. Traina
  • E. Stickeler
  • C.F. Singer
  • Z. Shao
  • X. Liu
  • H. Tipping10
  • G. Aktan
  • M. Martinez
  • J. L. Canon
  • M. Takahashi
  • H. Yasojima
  • K. Middleton
  • G. Pristauz-Telsnigg
  • G. Pfeiler
  • S. Virani

60 listed; 67 in total.

40 affiliations
  1. 1Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, USA
  2. 2Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, UK
  3. 3Department of Biostatistics, Frontier Science (Scotland), Kincraig, Scotland, UK
  4. 4NRG Oncology/NSABP Foundation, Pittsburgh, USA
  5. 5Department of Biostatistics, University of Pittsburgh, Pittsburgh, USA
  6. 6Oncology Biometrics Department, AstraZeneca, Macclesfield, UK
  7. 7R&D Department, Breast International Group (BIG), Brussels, Belgium
  8. 8Department of Medicine, UPMC Hillman Cancer Center, Pittsburgh, USA
  9. 9Department of Data Management, Frontier Science (Scotland), Kincraig, Scotland, UK
  10. 10Late Development, Oncology Research and Development, AstraZeneca, Cambridge, UK
  11. 11Department of Cancer Medicine, Institute Gustave Roussy and Unicancer Breast Group, Paris, France
  12. 12Taiwan Cooperative Oncology Group, Division of Cancer Research, National Institute of Cancer Research, National Health Research Institutes, Taipei City, Taiwan
  13. 13Department of Internal Medicine, Division of Medical Oncology, University of Kansas Medical Center, Westwood, USA
  14. 14Department of Oncology-Pathology, Swedish Breast Cancer Group, Cancer Research KI, Karolinska Institute Breast Center, Cancer Theme Karolinska University Hospital, Karolinska Comprehensive Cancer Center, Stockholm, Sweden
  15. 15Department for Obstetrics and Gynecology, Universitaetsklinikum, University of Ulm, Ulm, Germany
  16. 16Medical Oncology Department, Vall d’Hebron Institute of Oncology and Vall d’Hebron University Hospital, Barcelona, Spain
  17. 17Department of Hematology, Oncology, and Radiation Physics, Swedish Association of Breast Oncologists, Skåne University Hospital, Lund, Sweden
  18. 18Department of Patient Advocacy, Europa Donna - The European Breast Cancer Coalition, Milan, Italy
  19. 19Europa Donna Slovenia, Ljubljana, Slovenia
  20. 20Facing Our Risk of Cancer Empowered, Tampa, USA
  21. 21Department of Pathology, University of Pittsburgh, Pittsburgh, USA
  22. 22Department of Medical Oncology, The Christie Hospital NHS Foundation Trust, Manchester, UK
  23. 23Clinical Investigations Branch, Division of Cancer Treatment and Diagnosis, The National Cancer Institute, Rockville, USA
  24. 24Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine Cancer Research Institute, Seoul National University, Seoul, Republic of Korea
  25. 25Department of Breast and Thyroid Surgical Oncology, Hakuaikai Sagara Hospital, Kagoshima, Japan
  26. 26Department of Pathology and Laboratory Medicine, IEO European Institute of Oncology IRCCS, Milan, Italy
  27. 27Departement of Clinical Trials and Statistics Unit (ICR-CTSU), The Institute of Cancer Research, London, UK
  28. 28Department of Oncology, International Breast Cancer Study Group, Bern, Switzerland
  29. 29Department of Medical Oncology, Ospedale Infermi AUSL della Romagna, Rimini, Italy
  30. 30Department of Medical Oncology, Landspítali University Hospital of Iceland, Icelandic Breast Cancer Group, Reykjavik, Iceland
  31. 31Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC), Parma, Italy
  32. 32Department of Internal Medicine and Medical Specialties (DiMI), Università degli Studi di Genova and IRCCS Ospedale Policlinico San Martino, Genoa, Italy
  33. 33Consorcio Hospitalario Provincial de Castellón, Servicio de Oncología Médica, Castellón, Spain
  34. 34GEICAM Spanish Breast Cancer Group, Madrid, Spain
  35. 35Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany
  36. 36German Breast Group, Neu-Isenburg, Germany
  37. 37Department of Clinical Research, Instituto de Oncologia De Rosario, Santa Fe, Argentina
  38. 38European Organisation for Research and Treatment (EORTC), Brussels, Belgium
  39. 39Department of Medical Oncology, Institut Bergonie, Bordeaux, France
  40. 40Department of Medicine/Oncology, Stanford University School of Medicine, Stanford, USA
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Abstract

BACKGROUND: The randomised phase III OlympiA trial (NCT02032823) compared 1 year of adjuvant olaparib [oral poly (ADP-ribose) polymerase inhibitor] with placebo in 1836 patients with pathogenic/likely pathogenic BRCA1 or BRCA2 [germline BRCA pathogenic variants (gBRCApvs)] germline variants and high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (BC). Previous interim analyses (IAs) demonstrated statistically significant improvements in invasive disease-free survival (IDFS), distant disease-free survival (DDFS) and overall survival (OS), irrespective of hormone receptor status, prior platinum administration, timing of prior chemotherapy or type of gBRCApv. Herein are the results of the third prespecified IA with a median follow-up (MFU) of 6.1 years. PATIENTS AND METHODS: Descriptive analyses are presented for the primary endpoint IDFS and key secondary endpoints of DDFS and OS. Estimates of the hazard ratio (HR) based on the stratified Cox's proportional hazards model and 95% confidence intervals (CIs) are presented with yearly event rates at an MFU of ≤6.1 years. Safety analyses included adverse events of special interest (AESIs). RESULTS: Olaparib benefits were maintained in IDFS (HR 0.65, 95% CI 0.53-0.78), DDFS (HR 0.65, 95% CI 0.53-0.81) and OS (HR 0.72, 95% CI 0.56-0.93). The 6-year OS for olaparib versus placebo was 87.5% versus 83.2% (difference 4.4%, 95% CI 0.9% to 6.7%). Olaparib benefit was consistent across all key subgroups, including patients with high-risk hormone receptor-positive disease. There were fewer BRCA-associated new BC and ovarian/fallopian tube cancer cases and there was no increase in AESI risks (6.3% versus 9.3%), including myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) (0.4% versus 0.7%), with olaparib versus placebo. CONCLUSIONS: At an MFU of 6.1 years, 1 year of adjuvant olaparib after (neo)adjuvant chemotherapy demonstrated ongoing clinically meaningful improvements in IDFS, DDFS and OS in patients with gBRCApvs and high-risk, HER2-negative early BC, with acceptable toxicity and without increased risk of MDS/AML. These data continue to provide support for adjuvant olaparib in the treatment of gBRCApv-associated high-risk, HER2-negative early BC.

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Cite

BibTeXRIS
BibTeX
@article{garber2026sustained,
  title = {{Sustained benefit of adjuvant olaparib in women with germline BRCA1- and BRCA2- -associated high-risk HER2-negative early breast cancer: Updated results from the OlympiA phase III trial}},
  author = {J. E. Garber and D. Cameron and C. Campbell and G. Yothers and M. Taboada and S. El-abed and P. Rastogi and R. McConnell and A. Correa and S. Delaloge and W. T. Liu and P. Sharma and J. Bergh and W. Janni and J. Balmaña and N. Loman and T. Španić and S. Friedman and T. Freeman and A. Armstrong and L. Korde and S. Im and Y. Sagara and G. Viale and J. Bliss and L. Gianni and Ó. Jóhannsson and G. Zoppoli and E. Martinez De Dueñas and F. Marmé and L. Fein and M. Arnedos and J. Ford and R. Schmutzler and S. Loibl and B. Linderholm and S. R. Lakhani and M. Gnant and K. Gelmon and S. M. Domchek and E. Senkus and A. Eisen and A. Jager and M. Piccart and KA. Phillips and T. Traina and E. Stickeler and C.F. Singer and Z. Shao and X. Liu and H. Tipping and G. Aktan and M. Martinez and J. L. Canon and M. Takahashi and H. Yasojima and K. Middleton and G. Pristauz-Telsnigg and G. Pfeiler and S. Virani},
  journal = {Annals of oncology : official journal of the European Society for Medical Oncology},
  year = {2026},
  month = aug,
  doi = {10.1016/j.annonc.2026.08.002},
  url = {https://doi.org/10.1016/j.annonc.2026.08.002},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Sustained benefit of adjuvant olaparib in women with germline BRCA1- and BRCA2- -associated high-risk HER2-negative early breast cancer: Updated results from the OlympiA phase III trial
AU  - J. E. Garber
AU  - D. Cameron
AU  - C. Campbell
AU  - G. Yothers
AU  - M. Taboada
AU  - S. El-abed
AU  - P. Rastogi
AU  - R. McConnell
AU  - A. Correa
AU  - S. Delaloge
AU  - W. T. Liu
AU  - P. Sharma
AU  - J. Bergh
AU  - W. Janni
AU  - J. Balmaña
AU  - N. Loman
AU  - T. Španić
AU  - S. Friedman
AU  - T. Freeman
AU  - A. Armstrong
AU  - L. Korde
AU  - S. Im
AU  - Y. Sagara
AU  - G. Viale
AU  - J. Bliss
AU  - L. Gianni
AU  - Ó. Jóhannsson
AU  - G. Zoppoli
AU  - E. Martinez De Dueñas
AU  - F. Marmé
AU  - L. Fein
AU  - M. Arnedos
AU  - J. Ford
AU  - R. Schmutzler
AU  - S. Loibl
AU  - B. Linderholm
AU  - S. R. Lakhani
AU  - M. Gnant
AU  - K. Gelmon
AU  - S. M. Domchek
AU  - E. Senkus
AU  - A. Eisen
AU  - A. Jager
AU  - M. Piccart
AU  - KA. Phillips
AU  - T. Traina
AU  - E. Stickeler
AU  - C.F. Singer
AU  - Z. Shao
AU  - X. Liu
AU  - H. Tipping
AU  - G. Aktan
AU  - M. Martinez
AU  - J. L. Canon
AU  - M. Takahashi
AU  - H. Yasojima
AU  - K. Middleton
AU  - G. Pristauz-Telsnigg
AU  - G. Pfeiler
AU  - S. Virani
PY  - 2026
DA  - 2026/08/24
JO  - Annals of oncology : official journal of the European Society for Medical Oncology
DO  - 10.1016/j.annonc.2026.08.002
UR  - https://doi.org/10.1016/j.annonc.2026.08.002
AB  - BACKGROUND: The randomised phase III OlympiA trial (NCT02032823) compared 1 year of adjuvant olaparib [oral poly (ADP-ribose) polymerase inhibitor] with placebo in 1836 patients with pathogenic/likely pathogenic BRCA1 or BRCA2 [germline BRCA pathogenic variants (gBRCApvs)] germline variants and high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (BC). Previous interim analyses (IAs) demonstrated statistically significant improvements in invasive disease-free survival (IDFS), distant disease-free survival (DDFS) and overall survival (OS), irrespective of hormone receptor status, prior platinum administration, timing of prior chemotherapy or type of gBRCApv. Herein are the results of the third prespecified IA with a median follow-up (MFU) of 6.1 years. PATIENTS AND METHODS: Descriptive analyses are presented for the primary endpoint IDFS and key secondary endpoints of DDFS and OS. Estimates of the hazard ratio (HR) based on the stratified Cox's proportional hazards model and 95% confidence intervals (CIs) are presented with yearly event rates at an MFU of ≤6.1 years. Safety analyses included adverse events of special interest (AESIs). RESULTS: Olaparib benefits were maintained in IDFS (HR 0.65, 95% CI 0.53-0.78), DDFS (HR 0.65, 95% CI 0.53-0.81) and OS (HR 0.72, 95% CI 0.56-0.93). The 6-year OS for olaparib versus placebo was 87.5% versus 83.2% (difference 4.4%, 95% CI 0.9% to 6.7%). Olaparib benefit was consistent across all key subgroups, including patients with high-risk hormone receptor-positive disease. There were fewer BRCA-associated new BC and ovarian/fallopian tube cancer cases and there was no increase in AESI risks (6.3% versus 9.3%), including myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) (0.4% versus 0.7%), with olaparib versus placebo. CONCLUSIONS: At an MFU of 6.1 years, 1 year of adjuvant olaparib after (neo)adjuvant chemotherapy demonstrated ongoing clinically meaningful improvements in IDFS, DDFS and OS in patients with gBRCApvs and high-risk, HER2-negative early BC, with acceptable toxicity and without increased risk of MDS/AML. These data continue to provide support for adjuvant olaparib in the treatment of gBRCApv-associated high-risk, HER2-negative early BC.
SN  - 0923-7534
SN  - 1569-8041
ER  -