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FAQ Summary

Why is advanced ovarian cancer considered a serious disease?

Because women with advanced ovarian cancer are at risk of relapse.1,2

  • Ovarian cancer is the most common cause of death among gynecologic cancers in the US3
  • Most patients respond to first-line surgery and platinum-based chemotherapy; however, in the absence of maintenance therapy, 70% of patients relapse within 3 years1,2
  • Relapsed ovarian cancer is considered incurable and most patients will die from the disease;4,5 Therefore, the first line is likely to be the best setting for treatments to help prevent recurrence4,6

An understanding of the high recurrence rate in advanced ovarian cancer is critical to optimizing care and should drive every clinical decision after diagnosis to help delay recurrence and potentially extend survival. A biomarker-driven treatment approach is an option recommended by guidelines to personalize therapy and improve long-term outcomes.1,7,8

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What are the real-world HRD testing rates in advanced ovarian cancer?

In a retrospective study of biomarker testing in 1002 patients with epithelial ovarian cancer drawn from community health systems in the US (2018–2020), 74.7% (748/1002) underwent testing, and only 32.8% (245/747) of those tested were tested for BRCA mutations and a genomic instability biomarker (eg, LOH, GIS).9

Biomarker testing can help identify patients who may benefit from PARP inhibitor maintenance therapy regimens.10,11 With suboptimal testing rates, many patients may be missing the opportunity for targeted therapy.9

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Why is HRD testing critical to optimizing outcomes in patients with advanced ovarian cancer?

Early identification of HRD status can allow for the personalization of first-line therapy, helping identify patients who may benefit from PARP inhibitor maintenance therapy regimens.10,11

  • Patients with HRD-positive disease who receive PARP inhibitor-based maintenance therapy regimens can experience delayed time to recurrence12
  • Following the first relapse, each subsequent line of therapy is characterized by shorter treatment-free intervals, and cumulative toxicity13-15

Recurrence rates in advanced ovarian cancer have been demonstrated to be over 70% with most relapses occurring within the first 3 years of diagnosis.2,16

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Why is it important that testing for HRD in advanced ovarian cancer occur at diagnosis or as soon as possible afterwards?

Biomarker testing should occur as soon as possible after diagnosis so that biomarker status can inform treatment decisions and allow for determination of a biomarker-driven treatment plan.1,8,17

  • According to drug indications:
    • Select patients with BRCA mutations are eligible for LYNPARZA monotherapy1,8,12
    • Select patients with HRD-positive disease, who are eligible for LYNPARZA plus bevacizumab1,8,12

Upfront biomarker testing can help identify patients who may benefit from first-line PARP inhibitor maintenance therapy regimens.10,11

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Do treatment guidelines support the use of olaparib in combination with bevacizumab therapy in advanced ovarian cancer?

Treatment guidelines (including National Comprehensive Cancer Network® (NCCN®) and ASCO) recommend the combination of olaparib plus bevacizumab as first-line maintenance therapy option in selected patients with HRD-positive advanced ovarian cancer in complete or partial response to first-line platinum-based therapy.1,7,8

  • Olaparib in combination with bevacizumab is the ONLY PARP inhibitor option with an NCCN Category 1* recommendation for first-line maintenance treatment in HRD-positive advanced ovarian cancer, in patients who received bevacizumab as part of primary therapy.7
*NCCN Category 1: Based upon high-level evidence (≥1 randomized phase 3 trials or high-quality, robust meta-analyses), there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate.7
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.

Within the ovarian cancer setting, guidelines support a precision medicine approach:

  • Clinical practice guidelines support germline and tumor testing in all patients with ovarian cancer at diagnosis.1,7,8,17
  • Clinical practice guidelines recommend maintenance therapy as an option for select patients with advanced ovarian cancer after response to first-line treatment. Treatment determination can be based on biomarker status and prior bevacizumab use.1,7,8
  • Clinical practice guidelines recommended olaparib in combination with bevacizumab as an option in select patients with HRD-positive disease based on the results of the PAOLA-1 trial.1,7,8,12
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What evidence supports the use of first-line combination maintenance therapy in patients with advanced ovarian cancer?

The results of the PAOLA-1 clinical trial of LYNPARZA plus bevacizumab support the combination as a treatment for patients with HRD-positive* advanced ovarian cancer after response to first-line platinum-based chemotherapy12

*Including BRCA mutation (as determined by Myriad MyChoice® CDx) and other causes of HRD. HRD-positive is defined as either a tumor BRCA mutation and/or an HRD score ≥42 by Myriad MyChoice® CDx.11,18

The results of PAOLA-1 demonstrate that a personalized biomarker-driven approach should be leveraged to help delay recurrence in patients with HRD-positive disease.

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What type of patient should receive this combination?

The ideal patient profile includes the following key characteristics:

  • Newly diagnosed, advanced ovarian cancer (stage III–IV)18
  • HRD-positive tumor (including BRCA-mutated and non-BRCA, HRD-positive)12
  • In partial or complete response after completion of first-line chemotherapy plus bevacizumab18

A more thorough breakdown includes:

  1. Newly diagnosed, advanced disease
    • Advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer18
    • Histology: High-grade serous, high-grade endometrioid, or other epithelial non-mucinous ovarian cancer in patients with a deleterious germline BRCA mutation18
    • International Federation of Gynecology and Obstetrics (FIGO) stage III or IV18
    • Completed first-line therapy, including platinum-based chemotherapy plus bevacizumab18
  2. In response to first-line platinum-based chemotherapy
    • Partial or complete response or no evidence of disease18
    • No evidence of disease progression (physical examination, imaging, or CA-125) throughout and after first-line treatment18
  3. HRD-positive status
    • HRD-positive tumors are defined as11,12:
      • Deleterious or suspected deleterious BRCA1/2 mutations (germline or somatic), or
      • Non-BRCA HRD-positive, identified by positive genomic instability score; in PAOLA-1, positive was defined as Myriad myChoice® CDx genomic instability score ≥4218
  4. Bevacizumab eligibility
    • Able to tolerate bevacizumab
    • No conditions such as uncontrolled hypertension, recent major surgery or bleeding risk, grade 3–4 hemorrhage, history of gastrointestinal perforation, or fistula19
  5. Patients not suitable for maintenance therapy with LYNPARZA and bevacizumab include patients with:
    • Platinum-refractory disease (progression during first-line chemotherapy)18
    • HRD-negative disease12
    • Comorbidities and conditions that render a patient unsuitable for bevacizumab therapy, such as uncontrolled hypertension, gastrointestinal perforation, and fistulae19

Identifying the appropriate patient for maintenance therapy is critical to optimizing long-term outcomes as it supports identification of patients who are likely to derive the most benefit. However, the main key to patient identification is biomarker testing, which can predict likelihood of sensitivity to PARP inhibitor therapy.

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What were the PFS results of the PAOLA-1 trial?

The PAOLA-1 trial confirmed that LYNPARZA in combination with bevacizumab maintenance therapy improves PFS over placebo plus bevacizumab, establishing this regimen as a maintenance therapy option for patients with HRD-positive* advanced ovarian cancer.

  • PAOLA-1 studied LYNPARZA plus bevacizumab vs an active comparator (bevacizumab plus placebo) as maintenance therapy in advanced ovarian cancer18
  • A prespecified exploratory subgroup analysis showed clinically meaningful PFS benefit in HRD-positive* (including tumor BRCA-mutated) patients after response to first-line chemotherapy.† FDA approval was based on this prespecified exploratory HRD-positive subgroup12,18,20
    • Median PFS was 3.1 years (37.2 months) with LYNPARZA plus bevacizumab vs ~1.5 years (17.7 months) with bevacizumab plus placebo18
    • 67% risk reduction of disease progression or death; HR=0.33 (95% CI 0.25–0.45)18
    • Data were based upon a prespecified exploratory subgroup analysis, which was not controlled for Type 1 error. HRD status was not a stratification factor in PAOLA-118
  • In a prespecified exploratory analysis of HRD-negative and HRD-unknown patients, there was insufficient evidence to suggest differential efficacy between the combination of LYNPARZA plus bevacizumab and bevacizumab plus placebo1
*Including BRCA mutation (as determined by Myriad MyChoice® CDx) and other causes of HRD. HRD-positive is defined as either a tumor BRCA mutation and/or an HRD score ≥42 by Myriad MyChoice® CDx.11,18
†Secondary endpoint: Prespecified exploratory analysis of PFS in the HRD-positive subgroup. Data based upon a prespecified exploratory subgroup analysis, which was not controlled for Type 1 error. HRD status was not a stratification factor in PAOLA-1. The analysis is based on Kaplan–Meier estimates and is descriptive only. This trial was not designed to assess a statistical difference between treatment groups at 5 years.6

These results support HRD testing to identify which patients are most likely to benefit and reinforce why HRD testing is critical for treatment decisions.12

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Why are the overall survival (OS) data of the PAOLA-1 trial crucial to our understanding of advanced ovarian cancer treatment?

The OS data provide evidence of long-term survival based on durable disease control in a cancer with a high recurrence rate.

  • Prespecified exploratory analysis of the secondary endpoint overall survival (OS) in the HRD-positive* subgroup showed a clinically meaningful survival benefit after response to first-line chemotherapy†6,20
  • Median OS was 6.3 years (75.2 months) with LYNPARZA plus bevacizumab vs ~4.8 years (57.3 months) with bevacizumab plus placebo6
    • 38% reduction in the risk of death; HR=0.62 (95% CI 0.45–0.85)
  • Data was based upon a prespecified exploratory subgroup analysis, which was not controlled for Type 1 error. HRD status was not a stratification factor in PAOLA-16
  • In a prespecified exploratory analysis of HRD-negative and HRD-unknown patients, there was insufficient evidence to suggest differential efficacy between the combination of LYNPARZA plus bevacizumab and bevacizumab plus placebo18

*Including BRCA mutation (as determined by Myriad MyChoice® CDx) and other causes of HRD. HRD-positive is defined as either a tumor BRCA mutation and/or an HRD score ≥42 by Myriad MyChoice® CDx.11,18
†Secondary endpoint: Prespecified exploratory analysis of OS in the HRD-positive subgroup. Data based upon a prespecified exploratory subgroup analysis, which was not controlled for Type 1 error. HRD status was not a stratification factor in PAOLA-1. The analysis is based on Kaplan–Meier estimates and is descriptive only. This trial was not designed to assess a statistical difference between treatment groups at 5 years.6

LYNPARZA in combination with bevacizumab is the only maintenance combination therapy to demonstrate a clinically meaningful improvement in OS outcomes in patients with HRD-positive disease.6,20-22 The data demonstrate that maintenance therapy may extend survival and that certain patients can derive long-term benefit with sustained disease control.12

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What do the safety results from the PAOLA-1 trial tell us about the tolerability of this maintenance regimen?

The safety results from the PAOLA-1 trial demonstrated that the toxicity profile was consistent with the known adverse effects of each drug and that no new safety signals or unexpected toxicity arose.

  • Common adverse reactions (ARs) with LYNPARZA were generally consistent with the
    known safety profile of LYNPARZA monotherapy12
  • ARs and laboratory abnormalities from the primary analysis in PAOLA-1 were mostly Grades 1 and 212

Primary analysis:

  • Fatal adverse reactions occurred in 1 patient due to concurrent pneumonia and aplastic anemia. Serious adverse reactions occurred in 31% of patients who received LYNPARZA plus bevacizumab. Serious adverse reactions in >5% of patients included hypertension (19%) and anemia (17%)12
  • In addition, venous thromboembolism occurred more commonly in patients receiving LYNPARZA plus bevacizumab (5%) than in those receiving placebo plus bevacizumab (1.9%)12

At 5-year follow-up analysis:

  • No new safety signals were identified6
  • The incidence of MDS/AML/AA was 1.7% (9/535) in the LYNPARZA plus bevacizumab group and 2.2% (6/267) in the bevacizumab plus placebo group6
    • In the HRD-positive subgroup, the incidence of MDS/AML was 1.6% (4/255) in patients who received LYNPARZA plus bevacizumab and 2.3% (3/131) in patients who received bevacizumab plus placebo12
  • 22 (4.1%) new primary malignancy events occurred in the LYNPARZA plus bevacizumab group and 8 (3.0%) events occurred in the bevacizumab plus placebo group6
  • 7 (1.3%) pneumonitis events occurred in the LYNPARZA plus bevacizumab group and 2 (0.7%) events occurred in the bevacizumab plus placebo group6
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What do HRD tests measure?

HRD tests combine BRCA mutation analysis and assessments of genomic instability.

  • About half of high-grade serous ovarian cancers exhibit HRD23,24
  • All patients with BRCA mutations have HRD, but not all patients with HRD have BRCA mutations25
  • HRD tests, conducted on tumor tissue, include tests for25:
    • BRCA mutations
    • Genomic instability biomarkers

Testing for BRCA mutations alone will miss half of all patients who are HRD-positive.23,24 Guidelines recommend HRD testing in the absence of BRCA mutations at diagnosis as an option to guide treatment decisions in advanced ovarian cancer.1,7,8,17

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References

  1. González-Martín A, Harter P, Leary A, et al. Newly diagnosed and relapsed epithelial ovarian cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(10):833-848.
  2. Caruso G, Tomao F, Parma G, et al. Poly (ADP-ribose) polymerase inhibitors (PARPi) in ovarian cancer: Lessons learned and future directions. Int J Gynecol Cancer. 2023;33(4):431-443.
  3. American Cancer Society (ACS). Cancer Facts & Figures 2025. Atlanta, GA;2025. Accessed August 28, 2025. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf
  4. Lorusso D, Mouret-Reynier M-A, Harter P, et al. Updated progression-free survival and final overall survival with maintenance olaparib plus bevacizumab according to clinical risk in patients with newly diagnosed advanced ovarian cancer in the phase III PAOLA-1/ENGOT-OV25 trial. Int J Gynecol Cancer. 2024;34(4):550-558.
  5. Moore K, Colombo N, Scambia G, et al. Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2018;379(26):2495-2505.
  6. Ray-Coquard I, Leary A, Pignata S, et al. Olaparib plus bevacizumab first-line maintenance in ovarian cancer: final overall survival results from the PAOLA-1/ENGOT-ov25 trial. Ann Oncol. 2023;34(8):681-692.
  7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer. V.3.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed August 27, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. 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.
  8. Gaillard S, Lacchetti C, Armstrong DK, et al. Neoadjuvant chemotherapy for newly diagnosed, advanced ovarian cancer: ASCO guideline update. J Clin Oncol. 2025;43(7):868-891.
  9. Matsuno RK, Williams AFO, Sweetnam C, et al. Patterns of homologous repair deficiency and BRCA1/2 testing of ovarian and breast cancers: A real-world study of patients in community health settings in the United States. JCO Oncol Advances. 2025;(2).
  10. Myriad Genetic Laboratories, Inc. Myriad BRACAnalysis CDx® Technical Information. Accessed July 2, 2025. https://myriad-library.s3.amazonaws.com/technical-specifications/BRACAnalysis_CDx_Tech_Specs.pdf.
  11. Myriad Genetic Laboratories, Inc. Myriad MyChoice® CDx Technical Information. Accessed June 30, 2025. https://s3.amazonaws.com/myriad-web/myChoiceCDx/downloads/myChoiceCDxTech.pdf
  12. LYNPARZA® (olaparib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025.
  13. Eng KH, Hanlon BM, Bradley WH, Szender JB. Prognostic factors modifying the treatment-free interval in recurrent ovarian cancer. Gynecol Oncol. 2015;139(2):228-235.
  14. Lutgendorf SK, Shinn E, Carter J, et al. Quality of life among long-term survivors of advanced stage ovarian cancer: A cross-sectional approach. Gynecol Oncol. 2017;146(1):101-108.
  15. Dunton CJ. Management of treatment-related toxicity in advanced ovarian cancer. The Oncologist. 2002;7(S5):11-19.
  16. Ovarian Cancer Research Alliance. Recurrence. Accessed August 27, 2025. https://ocrahope.org/patients/about-ovarian-cancer/recurrence/.
  17. Gressel GM, Frey MK, Norquist B, Senter L, Blank SV, Urban RR. Germline and somatic testing for ovarian cancer: An SGO clinical practice statement. Gynecol Oncol. 2024;181:170-178.
  18. Ray-Coquard I, Pautier P, Pignata S, et al. Olaparib plus bevacizumab as first-line maintenance in ovarian cancer. N Engl J Med. 2019;381(25):2416-2428.
  19. Avastin® (bevacizumab) [prescribing information]. South San Francisco, CA: Genentech, Inc; 2022.
  20. Ellis LM, Bernstein DS, Voest EE, et al. American Society of Clinical Oncology Perspective: Raising the bar for clinical trials by defining clinically meaningful outcomes. J Clin Oncol. 2014;32(12):1277-1280.
  21. Hardesty MM, Krivak TC, Wright GS, et al. OVARIO phase II trial of combination niraparib plus bevacizumab maintenance therapy in advanced ovarian cancer following first-line platinum-based chemotherapy with bevacizumab. Gynecol Oncol. 2022;166(2):219-229.
  22. Monk BJ, Oaknin A, O’Malley D et al. ATHENA-COMBO, a phase III, randomized trial comparing rucaparib (RUCA) + nivolumab (NIVO) combination therapy vs RUCA monotherapy as maintenance treatment in patients (pts) with newly diagnosed ovarian cancer (OC). Ann Oncol. 2024;35:1223-1224.
  23. Konstantinopoulos PA, Ceccaldi R, Shapiro GI, D’Andrea AD. Homologous recombination deficiency: exploiting the fundamental vulnerability of ovarian cancer. Cancer Discov. 2015;5(11):1137-1154.
  24. Pennington KP, Walsh T, Harrell MI, et al. Germline and somatic mutations in homologous recombination genes predict platinum response and survival in ovarian, fallopian tube, and peritoneal carcinomas. Clin Cancer Res. 2014;20(3):764-775.
  25. Miller RE, Leary A, Scott CL, et al. ESMO recommendations on predictive biomarker testing for homologous recombination deficiency and PARP inhibitor benefit in ovarian cancer. Ann Oncol. 2020;31(12):1606-1622.

Abbreviations:

AR, adverse reaction; ASCO, American Society of Clinical Oncology; CA-125, cancer antigen 125; CDx, companion diagnostic; ESMO, European Society for Medical Oncology; FAQs, frequently asked questions; FDA, US Food and Drug Administration; FIGO, International Federation of Gynecology and Obstetrics; GIS, genomic instability score; HRD, homologous recombination deficiency; ITT, intent-to-treat; LOH, loss of heterozygosity; LST, large-scale transitions; NCCN, National Comprehensive Cancer Network® (NCCN®); OS, overall survival; PARP, poly (ADP-ribose) polymerase; PFS, progression-free survival; QoL, quality of life; TAI, telomeric allelic imbalance.

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