^
5ms
Liquid biopsy for the determination of homologous recombination deficiency in patients with high-grade serous ovarian cancer: Results of the BOVARY-pilot study (ESMO 2024)
Liquid biopsy shows promise as a surrogate for tissue biopsy in determining HRR-gene alterations, genomic instability, and BRCA1 and RAD51C methylation statuses, albeit with some limitations.
Clinical • PARP Biomarker • BRCA Biomarker • Liquid biopsy • Biopsy
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BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • RAD51C (RAD51 paralog C)
|
HRD
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Myriad myChoice® CDx Plus
5ms
Cytology-based HRD testing and BRCA mutational profiling in a set of ovarian cancer patients (ECP 2024)
Our data supports considering ascitic cytology samples suitable for HRD testing and BRCA1 and BRCA2 mutation analysis. Further studies are needed to validate the practice of using ascitic cytology as a diagnostic specimen for HRD testing when tissue is not accessible, as it could prove crucial to provide ovarian cancer patients with essential information in an early stage of the diagnostic process.
Clinical • PARP Biomarker • BRCA Biomarker • Cytology
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
|
BRCA2 mutation • BRCA1 mutation • HRD • HRD + BRCA1 mutation • BRCA1 mutation + BRCA2 mutation • BRCA mutation
|
Myriad myChoice® CDx Plus • SOPHiA DDM HRD Solution
5ms
Integrated molecular and clinico-pathological study of tubo-ovarian high grade serous carcinoma: HRD status and histological features (ECP 2024)
HRD positive tumours were specifically of high-grade morphology: HGSC and carcinosarcoma. The correlation of molecular status with histological features is important in order to be able to select the cases in which analysis is required. The majority of HGSCs with SET features are HRD tumours independently of BRCA status.
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset) • MUC16 (Mucin 16, Cell Surface Associated)
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HRD • BRCA wild-type • BRCA1 positive • BRCA2 positive
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Myriad myChoice® CDx Plus
6ms
Myriad Genetics collaborates with GSK to improve access to HRD testing in 9 countries (Myriad Genetics Press Release)
"Myriad Genetics, Inc...announced a collaboration with GSK aimed at improving access to homologous recombination deficiency (HRD) diagnostic testing for high-grade serous ovarian cancer (HGSOC) patients. A new sponsored testing program leveraging Myriad’s MyChoice HRD Plus and MyChoice CDx Plus Tests (collectively referred to as Myriad’s MyChoice Tests) is now available in Argentina, Brazil, Chile, Colombia, Egypt, Netherlands, Saudia Arabia, Singapore, and United Arab Emirates."
Licensing / partnership
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Myriad myChoice® CDx Plus
7ms
Chemotherapy response score (CRS) and efficacy of PARP inhibitor (PARPi) treatment in advanced epithelial ovarian cancer (AEOC) (ESMO-GC 2024)
22 patients (48%) received PARPi (2 olaparib, 10 niraparib). Due to small sample, we did not find any statistical differences on PFS in the different subgroups. Contrary to expectations, we did observe a tendency of longer PFS in CRS1/2 versus CRS3 for BRCAmut and HRD tumors, indicating no added value for CRS in these situations. In contrast, a tendency of better PARPi response in the CRS3 versus CRS1/2 was noticed in HRP subgroup, suggesting that platinum sensitivity according to CRS could predict a better PARPi response in HRP population.
Clinical • PARP Biomarker • BRCA Biomarker • Metastases
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
|
BRCA MASTR Plus Dx • Myriad myChoice® CDx Plus • OncoKitDx
|
Lynparza (olaparib) • Zejula (niraparib)
7ms
Neoadjuvant combination treatment of olaparib and pembrolizumab for patients with HRD-positive advanced ovarian cancer. (ASCO 2024)
Neoadjuvant combination treatment of olaparib and pembrolizumab showed promising efficacy and safety in patients with HRD-positive advanced ovarian cancer.
Clinical • PD(L)-1 Biomarker • PARP Biomarker • BRCA Biomarker • IO biomarker • Metastases
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
|
Myriad myChoice® CDx Plus
|
Keytruda (pembrolizumab) • Lynparza (olaparib)
7ms
A phase IV trial to confirm the efficacy of olaparib in combination with bevacizumab as maintenance frontline treatment of HRD-positive ovarian tumours (IOlanTHe). (ASCO 2024)
Eight centers have been activated and other 6 are waiting for the activation with 19 patients registered and 3 screening failures. The enrollment is continuing, according to protocol timeline (12 months for enrollment, 6 months for surgery and CT and 24 months for maintenance treatment).
Combination therapy • P4 data • Clinical • PARP Biomarker
|
HRD (Homologous Recombination Deficiency) • TP53BP1 (Tumor Protein P53 Binding Protein 1)
|
Myriad myChoice® CDx Plus
|
Avastin (bevacizumab) • Lynparza (olaparib)
10ms
Systematic analysis of HRD testing in ovarian cancer - development of recommendations for optimal assay performance. (PubMed)
"Considering histological and sample conditions, success rates of up to 98% can be achieved. Our comprehensive evaluation contributes to further standardization of recommendations on HRD testing in ovarian cancer, which will have a large impact on personalized therapeutic strategies in this highly aggressive tumor type."
Journal
|
Myriad myChoice® CDx Plus
10ms
Concordance between an FDA-approved companion diagnostic and an alternative assay kit for assessing homologous recombination deficiency in ovarian cancer. (PubMed, Gynecol Oncol)
Comparison between the Illumina and Myriad assays showed that overall HRD status, the individual components of BRCA analysis, and HRD GIS detection results were highly concordant (>93%), suggesting the TSO 500 HRD assay will approach the analytical accuracy of the FDA-approved Myriad assay.
Journal • FDA event • BRCA Biomarker • BRCA Companion diagnostic • Companion diagnostic • Discordant
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
|
BRCA2 mutation • BRCA1 mutation • HRD • HRD + BRCA1 mutation
|
TruSight Oncology 500 Assay • Myriad myChoice® CDx Plus • TruSight Oncology 500 HRD Assay
11ms
The Leuven PARPi Benefit Test As Improved Approach For Prediction Of PARPi Benefit In The PAOLA-1/ENGOTov25 Trial (ESGO 2024)
Introduction/Background PAOLA-1/ENGOTov25 trial showed PFS and OS benefit with PARP inhibitor (PARPi) and bevacizumab in maintenance treatment of BRCAm and homologous recombination deficient (HRD+) ovarian cancer...4% with olaparib vs placebo, respectively(HR0...There was no difference in 2yPFS with either a negative Leuven PARPi Benefit Test or a negative Myriad HRD test. Conclusion Leuven PARPi Benefit Test is an improved approach to detect benefit of PARPi in ovarian cancer patients suggesting a better predictive value compared with the Myriad test
PARP Biomarker • BRCA Biomarker
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
|
BRCA2 mutation • BRCA1 mutation
|
Myriad myChoice® CDx Plus
|
Avastin (bevacizumab) • Lynparza (olaparib)
11ms
T Cell Exhaustion Correlates With Homologous Recombination And Determines Survival In High Grade Serous Ovarian Cancer. (ESGO 2024)
Conclusion These results demonstrate an association between T-cell exhaustion and HRD. T-cell exhaustion is an independent predictor of disease outcome in HGSOC.
PD(L)-1 Biomarker • BRCA Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • HRD (Homologous Recombination Deficiency) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • CD4 (CD4 Molecule) • ENTPD1 (Ectonucleoside Triphosphate Diphosphohydrolase 1)
|
PD-L1 expression • HRD • HRD + BRCA wild-type • HAVCR2 expression
|
Myriad myChoice® CDx Plus
11ms
IMPACT OF MOLECULAR STATUS ON CHEMOTHERAPY RESPONSE SCORE (CRS) IN ADVANCED EPITHELIAL OVARIAN CANCER (AEOC) (ESGO 2024)
Conclusion In our cohort, BRCA1/2-mutated pts and HRD showed a trend towards a better response to NACT as opposed to BRCA-WT and HR proficient pts, according to CRS, although statistical significance is not reached due to the limited number of patients. Further research is guaranteed.
BRCA Biomarker • Metastases
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1)
|
BRCA2 mutation • BRCA1 mutation • ATM mutation • BRCA wild-type • BRIP1 mutation • BRCA mutation
|
BRCA MASTR Plus Dx • Myriad myChoice® CDx Plus • OncoKitDx
12ms
Genomic mutations and homologous recombination deficiency (HRD) score in Japanese patients with metastatic hormone-sensitive prostate cancer (mHSPC): The impact of intraductal carcinoma of the prostate (IDC-P). (ASCO-GU 2024)
Among Japanese mHSPC patients, IDC-P demonstrates significant associations with an elevated incidence of genetic alterations and increased HRD score, emphasizing its potential clinical significance.
Clinical • BRCA Biomarker • Metastases
|
TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • HRD (Homologous Recombination Deficiency) • CDK12 (Cyclin dependent kinase 12) • BRCA (Breast cancer early onset) • FOXA1 (Forkhead Box A1)
|
TP53 mutation • HRD • PTEN mutation • CDK12 mutation • BRCA mutation • PTEN mutation + TP53 mutation • High HRD score
|
Myriad myChoice® CDx Plus
1year
Shallow whole genome sequencing approach to detect Homologous Recombination Deficiency in the PAOLA-1/ENGOT-OV25 phase-III trial. (PubMed, Oncogene)
P3; The bevacizumab (bev)/olaparib (ola) maintenance regimen was approved for BRCA1/2-mutated (BRCAmut) and Homologous Recombination Deficient (HRD) high-grade Advanced Ovarian Cancer (AOC) first line setting, based on a significantly improved progression-free survival (PFS) compared to bev alone in the PAOLA-1/ENGOT-ov25 trial (NCT02477644), where HRD was detected by MyChoice CDx PLUS test. This benefit was significant also for BRCA1/2 wild-type tumors (40.8 versus 19.5 months, HR: 0.45 [95% CI: 0.26-0.76]). ShallowHRDv2 is a performant, clinically validated, and cost-effective test for HRD detection.
Journal • P3 data • PARP Biomarker • BRCA Biomarker
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
|
BRCA2 mutation • BRCA1 mutation • HRD • BRCA wild-type
|
Myriad myChoice® CDx Plus
|
Avastin (bevacizumab) • Lynparza (olaparib)
1year
IOLANTHE: First Line Treatment With Olaparib in Combination With Bevacizumab in HRD Positive Patients (clinicaltrials.gov)
P4; N=190; Recruiting; Sponsor:Mario Negri Institute for Pharmacological Research
Combination therapy • New P4 trial
|
HRD (Homologous Recombination Deficiency)
|
HRD
|
Myriad myChoice® CDx Plus
|
Avastin (bevacizumab) • Lynparza (olaparib)
1year
PRIMA/ENGOT-OV26/GOG-3012 Study: Long-term Conditional Progression-Free Survival (cPFS) (DGHO 2023)
Background: Niraparib (nir) showed a blinded independent central review–assessed PFS benefit as a first-line (1L) maintenance therapy (MT) in the primary analysis of PRIMA (data cut 17 May 2019) across biomarker subgroups, including a substantial benefit in patients (pts) with homologous recombination–deficient (HRd) tumours... A durable PFS benefit (nir vs PBO) was observed up to 4 y after randomisation in the ITT and HRd populations, as determined by IA. Pts free from disease progression or death at the 2-y landmark had a high probability of remaining free from progression or death at 4 y, supporting the use of nir as a 1L MT.
PARP Biomarker
|
HRD (Homologous Recombination Deficiency)
|
HRD
|
Myriad myChoice® CDx Plus
|
Zejula (niraparib)
1year
Ovarian High-grade Serous Carcinoma with Transitional-like (SET) Morphology: A Homologous Recombination-deficient Tumor. (PubMed, Hum Pathol)
"Our results show that the majority of HGSCs with SET features are homologous recombination deficient tumors independently of the BRCA status and highlight the importance of the homologous recombination repair tumor testing especially in BRCA wild-type tumors. Recognition of transitional cell variant of HGSCs may help to identify patients most likely to benefit from PARP inhibitors."
Journal
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ATM (ATM serine/threonine kinase) • HRD (Homologous Recombination Deficiency) • PALB2 (Partner and localizer of BRCA2) • CDK12 (Cyclin dependent kinase 12) • BRCA (Breast cancer early onset) • CHEK2 (Checkpoint kinase 2) • RAD51B (RAD51 Paralog B) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • CHEK1 (Checkpoint kinase 1) • BARD1 (BRCA1 Associated RING Domain 1) • RAD54L (DNA Repair And Recombination Protein RAD54) • FANCL (FA Complementation Group L) • PPP2R2A (Protein Phosphatase 2, Regulatory Subunit B, Alpha)
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BRCA2 mutation • BRCA1 mutation • HRD • ATM mutation • PALB2 mutation • BRCA wild-type • CDK12 mutation • BRIP1 mutation • HRD + BRCA1 mutation • RAD51C mutation • RAD51D mutation • RAD51B mutation • BARD1 mutation • CHEK1 mutation • RAD54L mutation • CHEK1 expression
|
Myriad myChoice® CDx Plus • SOPHiA DDM HRD Solution
over1year
Real-world results of homologous recombination deficiency testing: Comparison between two methods on 2,655 ovarian cancer patients in Spain (ESMO 2023)
Percentages of BRCAwt/GIS-, BRCAwt/GIS+, BRCAm, and invalid cases were almost identical. In conclusion, Sophia DDMTM Dx HRD solution shows a high interlaboratory agreement, providing clinically relevant molecular information, and improving the interaction between referral and reference centers.
Real-world evidence • Clinical • BRCA Biomarker • Real-world
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • CCNE1 (Cyclin E1) • PALB2 (Partner and localizer of BRCA2) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D)
|
BRCA2 mutation • BRCA1 mutation • HRD • PALB2 mutation • CCNE1 amplification • BRIP1 mutation • HRD + BRCA1 mutation • RAD51C mutation • RAD51D mutation • RAD51 mutation
|
Myriad myChoice® CDx Plus • SOPHiA DDM HRD Solution
over1year
Genetic characteristics of platinum-sensitive ovarian clear cell carcinoma. (PubMed, Jpn J Clin Oncol)
The subset of platinum-sensitive ovarian clear cell carcinomas includes a majority with pure ovarian clear cell carcinoma features that lack the homologous recombination deficiency phenotype.
Journal • BRCA Biomarker
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ATM (ATM serine/threonine kinase) • HRD (Homologous Recombination Deficiency)
|
BRCA2 mutation • BRCA1 mutation • HRD • ATM mutation • HRD + BRCA1 mutation • BRCA1 mutation + BRCA2 mutation
|
Myriad myChoice® CDx Plus • OncoGuide™ NCC Oncopanel System
over1year
PARP inhibitor predictive value of the Leuven HRD test compared with Myriad MyChoice CDx PLUS HRD on 468 ovarian cancer patients from the PAOLA-1/ENGOT-ov25 trial. (PubMed, Eur J Cancer)
A robust correlation between the Leuven HRD and Myriad test was observed. For HRD+ tumours, the academic Leuven HRD showed a similar difference in PFS and OS as the Myriad test.
Journal • PARP Biomarker • BRCA Biomarker
|
TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
|
HRD • HRD + BRCA wild-type
|
Myriad myChoice® CDx Plus
|
Lynparza (olaparib)
over1year
Efficacy of subsequent therapies in patients (pts) with advanced ovarian cancer (AOC) in the phase III PAOLA-1/ENGOT-ov25 trial according to whether disease progression occurred during or after the end of olaparib (ola) maintenance. (ASCO 2023)
Background: In the PAOLA-1/ENGOT-ov25 trial (NCT02477644), maintenance ola (a PARP inhibitor) + bevacizumab (bev) led to prolonged progression-free and overall survival vs placebo (pbo) + bev in AOC pts, specifically those with homologous recombination-deficient (HRD+) tumors (Ray-Coquard et al. In this post hoc exploratory analysis of PAOLA-1, the efficacy of subsequent CT at relapse appeared dependent on whether progression occurred during or after the end of ola treatment. Efficacy was reduced when relapse occurred during ola but was comparable between pts who progressed after ola vs pbo + bev pts. Clinical trial information: NCT02477644.
P3 data • Clinical • PARP Biomarker • BRCA Biomarker • Metastases
|
HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
|
HRD • BRCA mutation
|
Myriad myChoice® CDx Plus
|
Avastin (bevacizumab) • Lynparza (olaparib)
almost2years
Homologous Recombination Repair Gene Mutations to Predict Olaparib Plus Bevacizumab Efficacy in the First-Line Ovarian Cancer PAOLA-1/ENGOT-ov25 Trial. (PubMed, JCO Precis Oncol)
Acknowledging limitations of small subgroup sizes, non-BRCA HRRm gene panels were not predictive of PFS benefit with maintenance olaparib plus bevacizumab versus placebo plus bevacizumab in PAOLA-1, irrespective of the gene panel tested. Current gene panels exploring HRRm should not be considered a substitute for HRD determined by BRCA mutation status and genomic instability testing in first-line high-grade ovarian cancer.
Journal • PARP Biomarker • BRCA Biomarker
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • PALB2 (Partner and localizer of BRCA2) • BRCA (Breast cancer early onset) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D)
|
BRCA2 mutation • BRCA1 mutation • HRD • PALB2 mutation • BRIP1 mutation • HRD + BRCA1 mutation • RAD51C mutation • RAD51D mutation • BLM mutation • RAD51 mutation
|
Myriad myChoice® CDx Plus
|
Avastin (bevacizumab) • Lynparza (olaparib)
almost2years
Homologous Recombination Deficiency (HRD) Status in Rare Histotypes of Ovarian Carcinomas: A Single-Center Experience (USCAP 2023)
In our cohort, rare histotypes of ovarian carcinomas are characterized by morphological and molecular heterogeneity resulting in different clinical behaviour. The evaluation of molecular markers could improve potential novel target therapy for these uncommon tumors.
Clinical • PARP Biomarker • BRCA Biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • NRAS (Neuroblastoma RAS viral oncogene homolog) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
|
TP53 mutation • BRAF mutation • PIK3CA mutation • HER-2 mutation • HRD
|
Myriad myChoice® CDx Plus
almost2years
Maintenance olaparib plus bevacizumab (bev) in patients (pts) with newly diagnosed advanced ovarian cancer (OC): 5-year (y) progression-free survival (PFS) by molecular subgroup in the PAOLA-1/ENGOT-ov25 trial (ESMO-GC 2023)
tBRCAm status by central labs and HRD status by Myriad MyChoice HRD Plus.*Kaplan–Meier estimates.CI, confidence interval; HR, hazard ratio; ITT, intent-to-treat. Conclusions The 5-y updated descriptive PFS rates suggest the benefit of adding olaparib to bev is sustained beyond end of treatment and may indicate the potential of cure in HRD+ newly diagnosed advanced OC, supporting use of maintenance olaparib + bev as a standard of care in pts with HRD+ tumours, regardless of tBRCAm status.
Clinical • PARP Biomarker • BRCA Biomarker • Metastases
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
|
BRCA2 mutation • BRCA1 mutation • HRD
|
Myriad myChoice® CDx Plus
|
Avastin (bevacizumab) • Lynparza (olaparib)
almost2years
5-year (y) overall survival (OS) with maintenance olaparib (ola) plus bevacizumab (bev) by clinical risk in patients (pts) with newly diagnosed advanced ovarian cancer (AOC) in the Phase III PAOLA-1/ENGOT-ov25 trial (ESMO-GC 2023)
Conclusions This post hoc analysis of 5-y OS suggests that adding maintenance ola to bev should be considered for all HRD+ pts with newly diagnosed AOC, irrespective of their clinical risk status. Particular benefit was observed in HRD+ lower-risk pts who achieved 5-y OS rates of 88.3%.
P3 data • Clinical • PARP Biomarker • BRCA Biomarker • Metastases
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
|
BRCA2 mutation • BRCA1 mutation • HRD
|
Myriad myChoice® CDx Plus
|
Avastin (bevacizumab) • Lynparza (olaparib)
almost2years
PRIMA/ENGOT-OV26/GOG-3012 study: long-term conditional PFS (ESMO-GC 2023)
Background Niraparib (nir) showed a blinded independent central review–assessed PFS benefit as a first-line (1L) maintenance therapy (MT) in the primary analysis of PRIMA (data cut 17 May 2019) across biomarker subgroups, including a substantial benefit in patients (pts) with homologous recombination–deficient (HRd) tumours...Pts free from disease progression or death at the 2-y landmark had a high probability of remaining free from progression or death at 4 y, supporting the use of nir as a 1L MT. Table: 33O HRd Nir PBO Landmark time from randomization Events/total pts 2-y probability from landmark, % (95% CI) Events/total pts 2-y probability from landmark, % (95% CI) 0 137/247 51 (44–57) 98/126 29 (21–37) 1 y 69/159 62 (54–70) 33/57 50 (36–62) 2 y 26/110 74 (64–82) 11/34 60 a ITT Landmark time from randomization Nir PBO Events/total pts 2-y probability from landmark, % (95% CI) Events/total pts 2-y probability from landmark, % (95% CI) 0 332/487 36 (31–40) 199/246 22 (17–28) 1 y 124/244 54 (47–60) 54/92 46 (36–56) 2 y 42/152 67 (57–76) 15/51 64 a a 95% CI were not calculated at time points with <10 pts.
PARP Biomarker
|
HRD (Homologous Recombination Deficiency)
|
HRD
|
Myriad myChoice® CDx Plus
|
Zejula (niraparib)
2years
Final overall survival (OS) results from the phase III PAOLA-1/ENGOT-ov25 trial evaluating maintenance olaparib (ola) plus bevacizumab (bev) in patients (pts) with newly diagnosed advanced ovarian cancer (AOC) (ESMO Asia 2022)
of events / no. of pts (%) 5 y OS rate, % HR (95% CI) Ola + bev Pbo + bev Ola + bev Pbo + bev ITT 288/537 (53.6) 158/269 (58.7) 47.3 41.5 0.92 (0.76–1.12) HRD+§ 93/255 (36.5) 69/132 (52.3) 65.5 48.4 0.62 (0.45–0.85) tBRCAm§ 48/157 (30.6) 37/80 (46.3) 73.2 53.8 0.60 (0.39–0.93) HRD+ excluding tBRCAm§ 44/97 (45.4) 32/55 (58.2) 54.7 44.2 0.71 (0.45–1.13) HRD-/unknown§ 195/282 (69.1) 89/137 (65.0) 30.6 34.9 1.14 (0.89–1.48) HRD-§ 140/192 (72.9) 58/85 (68.2) 25.7 32.3 1.19 (0.88–1.63) *tBRCAm status by central labs; HRD status by Myriad myChoice HRD Plus; §Preplanned exploratory analysis Conclusions Despite a high proportion of pts in the control arm receiving a PARP inhibitor post-progression, ola + bev provided a clinically meaningful improvement in OS for 1L HRD+ pts with and without a tBRCAm, confirming ola + bev as standard of care in this setting.
P3 data • Clinical • PARP Biomarker • BRCA Biomarker
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
|
BRCA2 mutation • BRCA1 mutation • HRD
|
Myriad myChoice® CDx Plus
|
Avastin (bevacizumab) • Lynparza (olaparib)