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A
ESMO-MCBS v1.1
Scorecard version: 1

Indication details

Tumour Type
Breast Cancer
Tumour Sub-type
Early Breast Cancer
Tumour Sub-Group
gBRCAm HER2-negative
Tumour stage
Adjuvant
Control Arm
Placebo
Treatment Setting
Adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated HER2-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant ChT
Trial Name
OlympiA

Primary Outcome(s)

Primary Outcome(s)
iDFS at 3-years
Evaluated Outcome
iDFS
Form(s)
Form 1

Outcome Data

DFS Control
77.10%
DFS Gain
8.8%
DFS HR
0.58 (99.5% CI, 0.41–0.82)

Final Score (after adjustments)

Final curative score
A
Comment
EMA (CHMP) June 2022 pending EC decision
FDA approval March 2022
Issue date
21.04.2022
Release date
21.04.2022
Last update
07.07.2022

ChT; chemotherapy; DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; FFS, failure-free survival; HR, hazard ratio; HRD, homologus recombination deficiency; HRP, homologous recombination proficient; iDFS, invasive disease-free survival; ITT, intention to treat; MFS, metastasis-free survival; NS, not significant; ORR, overall response rate; OS, overall survival; pCR, pathologic complete response/remission; PE, point estimate; PFS, progression-free survival; QoL, quality of life; RFS, relapse-free survival; RR, response rate; rPFS, radiographic progression-free survival; SD, stable disease; SSA, somatostatin analogue; SSTR, somatostatin receptor; TKI, tyrosine kinase inhibitor, TTP, time to progression; WT, wild type

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