Precision Medicine for Ovarian Cancer

Tumor Types & Biomarkers
Tumor Types & Biomarkers

Explore clinical guidelines on why, whom and how to test actionable biomarkers in lung, breast, ovarian and prostate cancers.
- Lung Tumor
  
  EGFR
  
  ERBB2 (HER2)
- Breast Tumor
  
  BRCA1/2
  
  ESR1
  
  HER2
  
  PIK3CA/AKT1/PTEN
- Ovarian Tumor
  
  HRD
- Prostate Tumor
  
  HRRm
  
  PTEN
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Ovarian Cancer

Ovarian Cancer

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Biomarkers
Prevalence
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Considerations for Your Practice
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Biomarker Testing Is Transforming the Management of Ovarian Cancer

Biomarker testing in ovarian cancer can predict treatment response, prognosis, and suitability for targeted therapy, informing decisions at all stages of the treatment journey, from diagnosis through recurrence.^1–3

Test All Newly Diagnosed Patients With Advanced Ovarian Cancer for Actionable Biomarkers

NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines^®) for ovarian
cancer recommend genetic risk evaluation, and germline and somatic testing (if not done previously), for all patients with advanced ovarian cancer.²

In the upfront setting, somatic testing may optimize the identification of molecular alterations that can inform the use of interventions for patients with homologous recombination deficiency (HRD).² HRD can be caused by mutations in BRCA1 or BRCA2, or in the absence of a BRCA mutation, other measures of genomic instability, including loss of heterozygosity (LOH), telomeric allelic imbalance (TAI), and large-scale state transitions (LST).³

NCCN Guidelines® recommendations²:

NCCN Guideline recommendations for ovarian cancer diagnosis and testing

Comprehensive surgical staging and debulking (if needed)

Genetic risk evaluation and germline or somatic BRCA1/2m testing

Germline or somatic BRCA1/2m negative

Germline or somatic BRCA1/2m positive

Germline or somatic BRCA1/2m negative

HRD tissue testing

HRD negative

HRD positive

HRD negative

May inform magnitude of benefit with PARPi maintenance therapy

Following on from the NCCN Guidelines, consider following the ASCO and SGO recommendations to carry out both germline and somatic testing, including HRD, at diagnosis for optimal treatment of patients with advanced ovarian cancer.^3,4

ASCO and SGO provide actionable recommendations for biomarker testing. They recommend germline genetic testing for ovarian cancer susceptibility genes including BRCA1/2, and somatic testing for ovarian cancer BRCA1/2 in the absence of pathogenic germline variants.^3,4 The SGO additionally states that somatic testing should determine HRD status (via measures of genomic instability including LOH, LST, TAI), to inform upfront treatment.³

Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Ovarian cancer V.3.2024. ©2024 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines^® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. The NCCN Guidelines are a work in progress that may be refined as often as new significant data becomes available.

Recommendations from the SGO practice statement³

Ovarian cancer diagnosis

Approach 1:

Concurrent Testing (Independent Test Ordering)

Test for germline BRCA1/2 status and for somatic BRCA1/2, LOH, HRD status

Approach 2:

Sequential Testing (Dependent Test Ordering)

Test for germline BRCA1/2 status. For patients with g BRCA1/2- negative status, also test for somatic BRCA1/2, LOH, HRD status

Approach 1:
Concurrent Testing
(Independent Test Ordering)

Approach 2:
Sequential Testing
(Dependent Test Ordering)

Germline Genetic
germline BRCA1/2

Somatic Tumor
somatic BRCA1/2, LOH, HRD status

gBRCA-negative

Adapted from Gressel et al. 2024.³

ASCO, American Society of Clinical Oncology; BRCA1/2, BReast CAncer susceptibility gene 1/2; BRCA1/2m, BReast CAncer susceptibility gene 1/2 mutation; gBRCA, germline BReast CAncer susceptibility gene; HRD, homologous recombination deficiency; LOH, loss of heterozygosity; LST, large-scale state transitions; NCCN, National Comprehensive Cancer Network; PARPi, poly-ADP ribose polymerase inhibitor; SGO, Society of Gynecologic Oncology; TAI, telomeric allelic imbalance.

Test for All Actionable Germline and Somatic Biomarkers at Diagnosis and Upon Recurrence^2,3

NCCN Guidelines recommend biomarker testing for patients with cancer, including but not limited to, ovarian cancer, fallopian tube cancer, or primary peritoneal cancer²

What to test²	When to test²
Biomarker	At diagnosis	Recurrence setting (if prior testing did not include these markers)
Germline BRCA1 and BRCA2 mutations
Somatic BRCA1 and BRCA2 mutations
LOH
HRD status	in the absence of gBRCA1/2 mutation
FRα (FOLR1)
HER2 (by IHC)
MSI
MMR
TMB
BRAF
RET
NTRK

BRAF, B-Raf proto-oncogene, serine/threonine kinase; BRCA1/2, BReast CAncer susceptibility gene 1/2; FDA, Food and Drug Administration; FOLR1, folate receptor alpha; g, germline; HER2, human epidermal growth factor receptor 2; HRD, homologous recombination deficiency; IHC, immunohistochemistry; LOH, loss of heterozygosity; MMR, mismatch repair; MSI, microsatellite instability; NCCN, National Comprehensive Cancer Network; NTRK, neurotrophic tyrosine receptor kinase; RET, rearranged during transfection; TMB, tumor mutational burden.

Approximately Half of Advanced Ovarian Cancer Cases Are HRD Positive^5–8

HRD status (consisting of BRCA1/2 and genomic instability [GIS] measures) provides predictive, prognostic, and familial insights to inform upfront treatment decisions with PARPis.^5–8

Pie chart representing cases of ovarian cancer that are HRD positive

~50%

~50% HRD-negative/Unknown^a

HRD-negative/Unknown^a

~25%

Non-BRCAm with evidence of LOH, TAI, LST

~8%

Somatic BRCAm

~17%

Germline BRCAm

~50%
HRD-positive^a

^aHomologous recombination status can be characterized as HRD-positive (HRD) or HRD-negative (HRP).

Comprehensive HRD testing (including germline and somatic BRCAm and GIS testing) can provide^9–13:

Predictive insights by indicating treatment eligibility and providing information on the magnitude of benefit of PARPis in certain patients with ovarian cancer
Prognostic insights—BRCA1/2m provides insight over the course of disease
Familial insights—germline BRCA1/2m aids in familial risk assessment

BRCAm, BReast CAncer susceptibility gene mutation; GIS, genomic instability; HRD, homologous recombination deficiency; HRP, homologous recombination proficiency; LOH, loss of heterozygosity; LST, large-scale state transitions; PARPi, poly-ADP ribose polymerase inhibitor; TAI, telomeric allelic imbalance.

Speak to a Precision Medicine team member about the sponsored testing program

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BRCA1/2, BReast CAncer susceptibility gene 1/2; CDx, companion diagnostic; HRD, homologous recombination deficiency.

Considerations for Your Practice

Investigate, action, or review MDT protocols for identifying patients eligible for biomarker testing, such as HRD status and BRCA1/2 mutations.

Review and ensure all eligible patients with ovarian cancer receive a biomarker test as recommended by NCCN Guidelines and the 2024 SGO clinical practice statement^2,3
Include somatic as well as germline testing to increase the detection of mutations and inform treatment^2,3
Consider testing for HRD status or genomic instability in the absence of germline BRCA1/2 mutations²
Find major testing labs in your area which can perform biomarker testing
Find solutions to common challenges you may face during biomarker testing

BRCA1/2, BReast CAncer susceptibility gene 1/2; HRD, homologous recombination deficiency; MDT, multidisciplinary team; NCCN, National Comprehensive Cancer Network; SGO, Society of Gynecologic Oncology.

Helpful Resources

Check out these featured resources on biomarker testing in ovarian cancer.

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View more resources

National Cancer Institute Surveillance, Epidemiology, and End Results Program (SEER). Cancer Statistics Review (CSR). 1975–2020 – Ovary. 2020; Accessed October 04, 2024. https://seer.cancer.gov/statistics-network/explorer/application.html?site=61&data_type=4&graph_type=2&compareBy=age_range&chk_age_range_9=9&chk_age_range_141=141&chk_age_range_157=157&relative_survival_interval=5&hdn_sex=3&race=1&stage=101&advopt_precision=1&advopt_show_ci=on&hdn_view=0&advopt_show_apc=on&advopt_display=1
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer. V.3.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed October 04, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org
Gressel GM, et al. Gynecol Oncol. 2024;181:170–178.
Konstantinopoulos PA, et al. J Clin Oncol. 2019;38(11):1222–1245.
Hoppe MM, et al. J Natl Cancer Inst. 2018;110(7):704–713.
Frey MK, Pothuri B. Gynecol Oncol Res Pract. 2017;4:4.
Cancer Genome Atlas Research Network. Nature. 2011;474(7353):609–615.
Konstantinopoulos PA, et al. Cancer Discov. 2015;5(11):1137–1154.
Mirza MR, et al. Ann Oncol. 2020;31(9):1148–1159.
Pellegrino B, et al. ESMO Open. 2019;4:e000480.
Heeke AL, et al. JCO Precis Oncol. 2018;2018:PO.17.00286.
Bolton KL, et al. JAMA. 2012;307(4):382–390.
Myriad Genetics. MyChoice^® CDx HRD Companion Diagnostic Test. Accessed October 08, 2024. https://myriad.com/mychoicecdx-astrazeneca/

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Precision Medicine for Ovarian Cancer

Biomarker Testing Is Transforming the Management of Ovarian Cancer

Test All Newly Diagnosed Patients With Advanced Ovarian Cancer for Actionable Biomarkers

NCCN Guidelines® recommendations²:

Recommendations from the SGO practice statement³

Test for All Actionable Germline and Somatic Biomarkers at Diagnosis and Upon Recurrence^2,3

Approximately Half of Advanced Ovarian Cancer Cases Are HRD Positive^5–8

Sponsored Testing Program for Myriad MyChoice^® CDx

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Speak to a Precision Medicine team member about the sponsored testing program

Considerations for Your Practice

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Precision Medicine for Ovarian Cancer

Biomarker Testing Is Transforming the Management of Ovarian Cancer

Test All Newly Diagnosed Patients With Advanced Ovarian Cancer for Actionable Biomarkers

NCCN Guidelines® recommendations2:

Recommendations from the SGO practice statement3

Test for All Actionable Germline and Somatic Biomarkers at Diagnosis and Upon Recurrence2,3

Approximately Half of Advanced Ovarian Cancer Cases Are HRD Positive5–8

Sponsored Testing Program for Myriad MyChoice® CDx

Enrollment

Speak to a Precision Medicine team member about the sponsored testing program

Considerations for Your Practice

Helpful Resources

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NCCN Guidelines® recommendations²:

Recommendations from the SGO practice statement³

Test for All Actionable Germline and Somatic Biomarkers at Diagnosis and Upon Recurrence^2,3

Approximately Half of Advanced Ovarian Cancer Cases Are HRD Positive^5–8

Sponsored Testing Program for Myriad MyChoice^® CDx