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Association details:
Biomarker:BARD1 mutation
Cancer:Ovarian Cancer
Drug:Lynparza (olaparib) (PARP inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

740P - Olaparib maintenance monotherapy for non-germline BRCA1/2-mutated (non-gBRCAm) platinum-sensitive relapsed ovarian cancer (PSR OC): Exploratory biomarker analyses of the phase IIIb OPINION study

Published date:
09/13/2021
Excerpt:
279 pts were enrolled and received olaparib maintenance (tablets; 300 mg bid)....12% of pts (34/279) had a non-BRCA HRRm (8 RAD51C; 7 BRIP1; 7 RAD51D; 3 CDK12; 2 FANCL; 2 PALB2; 1 ATM; 1 BARD1; 1 RAD51B; 1 CHEK2 and RAD51D; 1 PPP2R2A and RAD51C).....Pts with a non-BRCA HRRm achieved longer PFS benefit compared with the non HRRm subgroup.
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

To Assess the Efficacy and Safety of Olaparib Maintenance Monotherapy in the Treatment of Ovarian Cancer

Excerpt:
...Documented germline or somatic mutation in BRCA1 or BRCA2 genes that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function) [Genetic counselling for patients with germline BRCA mutations should be performed according to local regulations] Or Tumour BRCAwt status and documented qualifying mutation in any of 13 genes involved in the HRR pathway, excluding BRCA1 and BRCA2 (ATM, BARD1, BRIP1,CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D,and RAD54L), identified by the Lynparza HRR Assay in archival tumour tissue (i.e.,BRCA-independent HRRm) 4....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Excerpt:
...Difference in levels of PAR or PARP-1 before and after study treatment`Mutations in BRCA1/2, RAD51B, RAD51C, RAD51D, PPM1D, FANCM, BRIP1, PALB2 and BARD1 in germline tissue compared to tumor tissue...
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A study, performed in several centers, to examine the treatment of Olaparib at the time of disease progression in ovarian, peritoneal or fallopian tube cancer before an operation.

Excerpt:
...• Biological effects in the primary tumour following a short pre-operative course of treatment with Olaparib in patients with platinum sensitive relapsed ovarian cancer; the biological effects are assess in terms of the degree of PAR or PARP-1 inhibition (in tissue and ctDNA) • Germline HRD mutations and tissue mutation with respect to BRCA1/2, RAD51B, RAD51C, RAD51D, PPM1D, FANCM, BRIP1, PALB2 and BARD1 (in tissue and ctDNA)• Generate initial clinical efficacy data for future studies (RECIST 1.1)...