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

Olaparib maintenance monotherapy for non-germline BRCA1/2-mutated (non-gBRCAm) platinum-sensitive relapsed ovarian cancer (PSR OC) patients (pts): Phase IIIb OPINION interim analysis.

Published date:
05/13/2020
Excerpt:
Secondary endpoints included PFS by homologous recombination repair deficiency....the median PFS was 9.2 months (95% confidence interval [CI]: 7.6–10.9 months), with 152 PFS events (54.5% maturity). The Table presents PFS outcomes by key subgroups.
DOI:
10.1200/JCO.2020.38.15_suppl.6057
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

3955 - Phase III PAOLA-1/ENGOT-ov25 trial: Olaparib plus bevacizumab (bev) as maintenance therapy in patients (pts) with newly diagnosed, advanced ovarian cancer (OC) treated with platinum-based chemotherapy (PCh) plus bev

Published date:
09/28/2019
Excerpt:
The PFS benefit in pts with a tBRCAm and in HRD-positive pts was substantial.
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
New
Title:

Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer

Excerpt:
Of the 806 patients who underwent randomization, 537 were assigned to receive olaparib and 269 to receive placebo….The hazard ratio (olaparib group vs. placebo group) for disease progression or death was 0.33 (95% CI, 0.25 to 0.45) in patients with tumors positive for homologous recombination deficiency (HRD), including tumors that had BRCA mutations (median progression-free survival, 37.2 vs. 17.7 months), and 0.43 (95% CI, 0.28 to 0.66) in patients with HRD-positive tumors that did not have BRCA mutations (median progression-free survival, 28.1 vs. 16.6 months). Adverse events were consistent with the established safety profiles of olaparib and bevacizumab.
DOI:
10.1056/NEJMoa1911361
Trial ID:
Evidence Level:
Sensitive: C1 - Off-label
  (Approved for Prostate Cancer)
New
Excerpt:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated...for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone.
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients

Excerpt:
...Time to First Subsequent Therapy or Death (TFST)`Time to Treatment Discontinuation or Death (TDT)`PFS by Homologous Recombination Deficiency (HRD)/ Breast Cancer Susceptibility Gene Mutation (Mutated) (BRCAm) Status`Chemotherapy-free Interval (CT-FI)`Overall Survival (OS)`Percentage of Patients With Any Improvement From Baseline in Trial Outcome Index (TOI) Score at Any Point During the Treatment Period`Percentage of Patients With a 10-Point Deterioration From Baseline in TOI Score at Any Point During the Treatment Period...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
Title:

Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status

Excerpt:
...Duration of Response, for Those Subjects With a Confirmed Response of CR or PR`CA-125 Response Rate, Defined as the Percentage of Subjects With a CA-125 Response According to GCIG Criteria Divided by the Number of Subjects Evaluable for CA-125 Response`Disease Control Rate Defined as the Percentage of Subjects Who Have a Best Overall Response of CR or PR or SD at Greater Than or Equal to 8 Weeks Divided by the Number of Subjects in the Efficacy Analysis Set, Prior to Any PD Event`Progression Free Survival`Time to Any Progression`Overall Survival`HRD Status as Per HRRm Gene Panel Assessment Will be Correlated With Clinical Outcome (ORR) for Subjects Enrolled in the 2 Cohorts With BRCAwt (Cohorts 3 and 4)...
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

D9319C00001- 1L OC Mono Global RCT

Excerpt:
...Superiority of olaparib as maintenance treatment relative to placebo by assessment of PFS in participants with Stage III/IV ovarian cancer with a BRCAwt HRD positive tumour and a CR/PR following standard 1st line platinum based chemotherapy treatment.`...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy in Newly Diagnosed BRCAwt Ovarian Cancer

Excerpt:
...- Has documented HRD status based on available test results...
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

534P - A pilot study of neoadjuvant olaparib for patients with HRD-positive advanced ovarian cancer

Published date:
09/05/2022
Excerpt:
This is an open-label, multicenter pilot study evaluating the efficacy and safety of olaparib alone (cohort 1) or in combination with pembrolizumab (cohort 2) as neoadjuvant therapy in patients with HRD-positive stage III-IV ovarian cancer….Neoadjuvant olaparib monotherapy showed efficacy and tolerability in patients with HRD-positive advanced ovarian cancer.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

The correlation of homologous recombination deficiency status with and Olaparib efficacy in Chinese ovarian cancer patients.

Published date:
05/26/2022
Excerpt:
A significant PFS benefit was seen in HRD-positive patients compared with HRD-negative ones (P = 0.0017) or in the first-line maintenance treated population (P = 0.0068).
DOI:
10.1200/JCO.2022.40.16_suppl.e17556
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Olaparib treatment (Tx) in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSR OC) by BRCA mutation (BRCAm) and homologous recombination deficiency (HRD) status: Overall survival (OS) results from the phase II LIGHT study.

Published date:
05/19/2021
Excerpt:
Of 272 enrolled pts, 271 received olaparib...Consistent with the primary analysis, the 18-mo OS rate was highest in the BRCAm cohorts (similar OS in g and sBRCAm); among pts without a BRCAm, 18-mo OS was highest in the HRD +ve cohort.
DOI:
10.1200/JCO.2021.39.15_suppl.5515
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

ORZORA: Maintenance olaparib in patients with platinum-sensitive relapsed ovarian cancer: Outcomes by somatic and germline BRCA and other homologous recombination repair gene mutation status

Published date:
03/19/2021
Excerpt:
A total of 181 pts were enrolled in ORZORA (BRCAm n = 145 [s n = 55; g n = 87; n = 3 s vs g status unknown]; HRRm n = 33; unassigned n = 3) . Pt characteristics were similar between s and g cohorts: ≥3 prior lines of chemotherapy (38% vs 48%, respectively); partial response to prior platinum (45% vs 49%); tumor BRCA1-mutated (65% vs 64%)....Results highlight that PSROC pts beyond those with a gBRCAm can benefit from maintenance olaparib.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Olaparib treatment in patients (pts) with platinum-sensitive relapsed (PSR) ovarian cancer (OC) by BRCA mutation (BRCAm) and homologous recombination deficiency (HRD) status: Phase II LIGHT study.

Published date:
05/13/2020
Excerpt:
As observed in the maintenance setting, similar efficacy was seen in the gBRCAm and sBRCAm cohorts. For non-BRCAm pts, longer median PFS and higher ORR were observed in the HRD+ve cohort.
DOI:
10.1200/JCO.2020.38.15_suppl.6013
Trial ID: