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OlympiAD was a randomised, open-label, controlled, multicentre, Phase III trial designed to investigate the efficacy and safety of LYNPARZA vs. chemotherapy in patients with gBRCAm, HER2-negative mBC.1
Adapted from Robson M, et al. 2017.1
*Treatment of physician’s choice (eribulin, capecitabine or vinorelbine).1
LYNPARZA significantly prolonged mPFS by 2.8 months, with a mPFS of 7.0 months vs. 4.2 months with chemotherapy
(HR=0.58 [95% CI: 0.43–0.80]; P<0.001).1
PFS (assessed by BICR*) in patients with gBRCAm, HER2-negative mBC:1
Adapted from Robson M, et al. 2017.1
*PFS results that were based on investigator assessment were consistent with results based on BICR.1
Adapted from Robson M, et al. 2017.1
*Treatment of physician’s choice (eribulin, capecitabine or vinorelbine).1
*Confirmed responses (by BICR) were defined as a recorded response of either CR/PR, confirmed by repeat imaging not less than 4 weeks after the visit when the response was first observed. Data source: SmPC. Data cut-off: 9 December 2016.3
†TTR was assessed in patients with measurable disease who had a response to treatment – 100/167 LYNPARZA patients and 19/66 chemotherapy patients. Data source: OlympiAD trial. Data cut-off: December 2016.1
‡Investigator-assessed data from patients with measurable disease who had a response to treatment and were available for longer follow-up (n=111). Data source: OlympiAD trial. Data cut-off: 25 September 2017.2
§PFS2 assesses the time from treatment initiation to the second disease progression or death from any cause. Data source: SmPC. Data cut-off: 25 September 2017.3
AEs reported in ≥15% of patients in OlympiAD1*
Adapted from Robson M, et al. 2017.1
*Includes AEs of any grade that occurred in ≥15% of patients in either group and grade ≥3 AEs, which were graded according to the NCI CTCAE, version 4.0.1
†The neutropenia category included febrile neutropenia, granulocytopenia, decreased granulocyte count, neutropenia, neutropenic sepsis, decreased neutrophil count and neutropenic infection.1
‡The anaemia category included anaemia, decreased haemoglobin level, decreased haematocrit, decreased red-cell count and erythropenia.1
§205 patients were assigned to receive LYNPARZA. All 205 patients received treatment and were included in safety analyses.1
¶97 patients were assigned to receive standard therapy, 6 did not receive treatment owing to patient decision. 91 received treatment and were included in the safety analyses.1
Haematological toxicity and hepatotoxicity are listed as special warnings in the LYNPARZA SmPC. Please consult the SmPC for more information on AEs and their management prior to prescribing.3
*205 patients were assigned to receive LYNPARZA and all 205 received treatment and were included in safety analyses.1
†Treatment of physician’s choice (eribulin, capecitabine or vinorelbine). A total of 97 patients were assigned to receive standard therapy, 6 did not receive treatment owing to patient decision. 91 received treatment and were included in the safety analyses.1
OlympiAD included cancer-specific HRQoL outcomes to assess the patient experience during treatment with LYNPARZA7*
*The EORTC QLQ-C30 questionnaire was completed by the patient at baseline and every 6 weeks until disease progression (compliance rates were 93.2% for LYNPARZA and 76.3% for treatment of physician’s choice [eribulin, capecitabine or vinorelbine]).7
†Best overall response of improvement and deterioration were defined as a ≥10 point change from baseline and sustained for at least 21 days (for ‘improvement’, without an intervening visit response of ‘deterioration’; for ‘deterioration’, without an intervening response of ‘improved’ or ‘no change’).7
‡Censoring of most LYNPARZA-treated patients because they did not meet the 10-point threshold criterion for deterioration means that these TTD data should be interpreted with caution.7
LUCY was a Phase IIIb, open-label, single-arm, real-world study that followed 255 adults with gBRCAm, HER2-negative mBC receiving LYNPARZA 300 mg BID in routine practice.8
Outcomes were consistent with those seen in OlympiAD:8
The importance of
BRCA testing
OlympiA: clinical
trial in eBC
Educational and
patient resources
1L, first-line; aBC, advanced breast cancer; AE, adverse event; BICR, blinded independent central review; BID, twice daily; BRCA, breast cancer gene; CI, confidence interval; CR, complete response; DOR, duration of response; eBC, early breast cancer; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; gBRCAm, germline BRCA mutation; GHS, global health status, HER2, human epidermal growth factor receptor 2; HR+, hormone receptor positive; HR, hazard ratio; HRQoL, health-related quality of life; IQR, interquartile range; mBC, metastatic breast cancer; mPFS, median progression-free survival; NCI CTCAE, National Cancer Institute’s Common Terminology Criteria for Adverse Events; ORR, objective response rate; OS, overall survival; PARPi, poly (ADP-ribose) polymerase inhibitor; PFS(2), progression-free survival (2); PR, partial response; QoL, quality of life; SmPC, Summary of Product Characteristics; TEAE, treatment-emergent adverse event; TNBC, triple-negative breast cancer; TTD, time to deterioration; TTR, time to response.
GB-71739 | March 2026
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