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OlympiA was a Phase III, randomised, double-blind trial designed to investigate the efficacy and safety of adjuvant LYNPARZA vs. placebo in gBRCAm, HER2-negative, high-risk eBC.1,6
*Administered for a total of 12 months or until disease recurrence or unacceptable toxicity.1
†An anthracycline, taxane, or a combination of both. Prior platinum chemotherapy was allowed. For neoadjuvant patients, post-surgery chemotherapy was not allowed.1
‡IDFS was defined as the time from randomisation until the date of first occurrence of one of the following events: ipsilateral invasive breast tumour, locoregional invasive disease, distant recurrence, contralateral invasive breast cancer, second primary invasive cancer, or death from any cause.1
§DDFS was defined as the time from randomisation until the date of first occurrence of one of the following events: distant recurrence, second primary non-breast invasive cancer, or death from any cause.6
¶QoL was measured using the FACIT-F and EORTC QLQ-C30 questionnaires.6
IDFS* in the overall population:1†
Adapted from Tutt ANJ, et al. 2021. Data cut-off: 27 March 2020.1
*IDFS was defined as the time from randomisation until the date of first occurrence of one of the following events: ipsilateral invasive breast tumour, locoregional invasive disease, distant recurrence, contralateral invasive breast cancer, second primary invasive cancer, or death from any cause.1
†Based on a pre-specified event driven interim analysis with a median follow-up of 2.5 years.1
Significance boundaries were crossed for IDFS at the prior planned DCO1. No further significance testing was performed.
*IDFS results from DCO2 (17 December 2021), a pre-specified interim analysis with a median follow-up of 3.5 years.8
†IDFS results from DCO3 (5 June 2024), a descriptive analysis with a median follow-up of ~6.1 years.9
Adapted from Garber JE, et al. Oral presentation at SABCS, 2024.9
All subgroup hazard ratio estimates are <1 and all confidence intervals include the ITT population hazard ratio (shown by solid line).9
*DCO3 (5 June 2024), descriptive analysis at ~6.1 years median follow-up.9
OS at 6 years* in the overall population (descriptive analysis):9
Significance boundaries were crossed for IDFS and DDFS at the prior planned DCO1 and for OS at DCO2. No further significance testing was performed.
Adapted from Garber JE, et al. Oral presentation at SABCS, 2024.9
*6-year OS data are from DCO3 (5 June 2024), a descriptive analysis with a median follow-up of ~6 years in the ITT population.9
Subgroup analysis of OS (stratified subgroups):9
Significance boundaries were crossed for IDFS and DDFS at the prior planned DCO1 and for OS at DCO2. No further significance testing was performed.
Adapted from Garber JE, et al. Oral presentation at SABCS, 2024.9
All subgroup hazard ratio estimates are <1 and all confidence intervals include the ITT population hazard ratio (shown by solid black line).9
*6-year OS data are from DCO3 (5 June 2024), a descriptive analysis with a median follow-up of ~6 years in the ITT population.9
~75% of AEs experienced in patients receiving LYNPARZA were Grade 1 or 2 in severity.1
AEs occurring in ≥10% of patients on LYNPARZA or placebo at 3 years:1*
Adapted from Tutt ANJ, et al. 20211
*Based on a pre-specified event driven interim analysis with a median follow-up of 2.5 years.1
†All listed are Grade 3 except for 10 Grade 4 events in the LYNPARZA group: five events involving decreased neutrophil count, four involving anaemia and one involving fatigue.1
*Safety data from DCO2, a pre-specified interim analysis with a median follow-up of 3 years.8
†Nausea (2.1%), anaemia (1.8%), fatigue (1.5%) and decreased neutrophil count (1.0%) were the most common reasons for discontinuation of LYNPARZA.8
OlympiA included cancer-specific HRQoL outcomes to assess the patient experience during treatment with LYNPARZA. QoL was measured using the FACIT-F and EORTC QLQ-C30 questionnaires.11
The importance of
BRCA testing
OlympiAD: clinical
trial in mBC
Educational and
patient resources
AE, adverse event; BID, twice daily; BRCA, breast cancer gene; CI, confidence interval; DCO, data cut-off; DDFS, distant disease-free survival; eBC, early breast cancer; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; FACIT-F, Functional Assessment of Chronic Illness Therapy – Fatigue; gBRCAm, germline BRCA mutated; GHQ, general health questionnaire; HER2, human epidermal growth factor receptor 2; HR+, hormone receptor-positive; HR, hazard ratio; HRQoL, health-related quality of life; IDFS, invasive disease-free survival; ITT, intention-to-treat; mBC, metastatic breast cancer; OS, overall survival; PARPi, poly (ADP-ribose) polymerase inhibitor; QoL, quality of life; SABCS, San Antonio Breast Cancer Symposium; TNBC, triple-negative breast cancer.
GB-71736 | March 2026
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