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Breast cancer, metastatic

2434 - OlympiAD: Further efficacy outcomes in patients with HER2-negative metastatic breast cancer and a germline BRCA mutation receiving olaparib monotherapy vs standard single-agent chemotherapy treatment of physician’s choice

Date

10 Sep 2017

Session

Breast cancer, metastatic

Topics

Cytotoxic Therapy;  Breast Cancer

Presenters

Suzette Delaloge

Citation

Annals of Oncology (2017) 28 (suppl_5): v74-v108. 10.1093/annonc/mdx365

Authors

S. Delaloge1, P.F. Conte2, S. Im3, E. Senkus-Konefka4, B. Xu5, S.M. Domchek6, N. Masuda7, W. Li8, N. Tung9, A. Armstrong10, W. Wu11, C. Goessl11, S. Runswick12, M. Robson13

Author affiliations

  • 1 Breast Cancer Group, Institut Gustave Roussy, 94800 - Villejuif/FR
  • 2 Department Of Surgery, Oncology And Gastroenterology, University of Padova and Istituto Oncologico Veneto IRCCS, 35100 - Padova/IT
  • 3 Cancer Research Institute, Seoul National University College Of Medicine, Seoul National University Hospital, 110-744 - Seoul/KR
  • 4 Department Of Oncology And Radiotherapy, Medical University of Gdansk, 80-211 - Gdansk/PL
  • 5 Department Of Medical Oncology, National Caner Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 100021 - Beijing/CN
  • 6 Basser Center, University of Pennsylvania, Philadelphia/US
  • 7 Department Of Surgery, Breast Oncology, National Hospital Organization, Osaka National Hospital, 540-0006 - Osaka/JP
  • 8 ,, The First Hospital of Jilin University, Changchun/CN
  • 9 Beth Isreal Deaconess Medical Center, Dana-Farber Harvard Cancer Center, Boston/US
  • 10 Christie Hospital Nhs Foundation Trust, Faculty Of Biology, Medicine And Health, University of Manchester, Manchester/GB
  • 11 Global Medicines Development, AstraZeneca, Gaithersburg/US
  • 12 Global Medicines Development, AstraZeneca, Macclesfield/GB
  • 13 Clinical Genetics Service, Memorial Sloan Kettering Cancer Center, New York/US
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Resources

Abstract 2434

Background

The Phase III OlympiAD study (NCT02000622) in patients with metastatic breast cancer (mBC) and a germline BRCA mutation (gBRCAm) showed a statistically significant progression-free survival (PFS) benefit for olaparib monotherapy over chemotherapy treatment of physician’s choice (TPC; hazard ratio [HR] 0.58; 95% CI 0.43, 0.80; P

Methods

OlympiAD was a randomized, open-label, Phase III study of olaparib monotherapy vs TPC in HER2-negative mBC patients with a gBRCAm who had received ≤2 chemotherapy lines in the metastatic setting. Patients were randomized 2:1 to olaparib tablets (300 mg bid) or single-agent TPC (capecitabine, eribulin or vinorelbine). Patients had ≥1 lesion suitable for assessments according to modified RECIST 1.1. The primary endpoint was PFS by blinded independent central review.

Results

302 patients were randomized to olaparib (n = 205) or TPC (n = 97). In patients with measurable disease, objective response rate (ORR) was 59.9% for olaparib patients (n = 167; complete response [CR] 9.0%, partial response [PR] 50.9%, stable disease ≥5 weeks [SD] 25.1%; progressive disease [PD] 15.0%) and 28.8% for TPC patients (n = 66; CR 1.5%, PR 27.3%, SD 37.9%, PD 33.3%). Median best percentage change from baseline in target lesion size was −45.1% for olaparib and −14.8% for TPC.

Conclusions

Olaparib monotherapy in OlympiAD led to a doubling of ORR vs TPC and a larger reduction in target lesion size, indicating a more pronounced depth of response in HER2-negative gBRCAm mBC patients. PFS was longer with olaparib than with TPC, irrespective of tumour burden and location.

Clinical trial identification

NCT02000622, 15 June 2017

Legal entity responsible for the study

AstraZeneca

Funding

AstraZeneca

Disclosure

S. Delaloge: Honoraria, research funding, consulting, and travel, expenses and accommodation from Novartis, Roche, AstraZeneca, Pfizer, GE Healthcare, and Puma Biotechnology. P.F. Conte: Speakers’ bureau with Roche-Genentech, Novartis, AstraZeneca and Lilly, travel, accommodations, and expenses from Novartis, Celgene and AstraZeneca, and research funding from Roche, Novartis and Merck Serono. S-A. Im: Consultancy for Novartis, Hanmi and Spectrum Pharmaceuticals. E. Senkus-Konefka: Honoraria from Amgen, AstraZeneca, Pfizer, Pierre Fabre and Roche, and consulting for Amgen, AstraZeneca, Pfizer, Pierre Fabre and Roche. S.M. Domchek: Research funding to the University of Pennsylvania from AstraZeneca, Clovis Oncology, AbbVie and Pharmamar. N. Masuda: Honoraria from Chugai Pharma, AstraZeneca and Kyowa Hakko Kirin, and research funding from Chugai Pharma, AstraZeneca, Kyowa Hakka Kirin, MSD, Novartis, Pfizer and Lilly. N. Tung: Patents, royalties and other intellectual property with Ambry Genetics, and research funding from Myriad Genetics. A. Armstrong: Consulting for Roche and Syndax. W. Wu, C. Goessl, S. Runswick: Employee of and stock ownership in AstraZeneca. M. Robson: Consultancy for AstraZeneca and McKesson, travel, accommodation and expenses from AstraZeneca, honoraria from AstraZeneca and research funding from AstraZeneca, AbbVie, Myriad Genetics and Medivation. All other authors have declared no conflicts of interest.\r\nTable 243PD

Subgroup analyses for PFS by baseline tumour burden and location are shown in the Table.

\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n
\r\nOlaparib 300 mg bidChemotherapy TPC
Tumour burden
1 metastatic site, n4625
Median PFS, months8.44.2
HR (95% CI)0.62 (0.35, 1.13)
≥2 metastatic sites, n15972
Median PFS, months6.53.0
HR (95% CI)0.59 (0.43, 0.82)
Tumour location
Bone-only metastases, n166
Median PFS, months11.2
HR (95% CI)Not calculated
Other metastatic sites,* n18991
Median PFS, months6.63.9
HR (95% CI)0.60 (0.46, 0.81)
\r\n*

Includes both bone and other tumour locations

\r\n

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