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18 Efficacy of maintenance olaparib plus bevacizumab by biomarker status in clinical higher- and lower-risk patients with newly diagnosed, advanced ovarian cancer in the PAOLA-1 trial
  1. P Harter1,
  2. D Petran2,
  3. G Scambia3,
  4. E Ortega4,
  5. I Tsibulak5,
  6. S Nagao6,
  7. I Vergote7,
  8. J Meunier8,
  9. F Priou9,
  10. R Sverdlin10,
  11. T Milenkova11,
  12. I Ray-Coquard12 and
  13. I Ray-Coquard12
  1. 1Kliniken Essen Mitte, and AGO, Germany
  2. 2Centre Hospitalier Mont de Marsan, and GINECO, France
  3. 3Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica, and MITO, Italy
  4. 4Hospital Universitari Arnau de Vilanova, Spain
  5. 5Medical University of Innsbruck, and AGO-Austria, Austria
  6. 6Hyogo Cancer Center, and GOTIC, Japan
  7. 7University Hospital Leuven, Leuven Cancer Institute, and BGOG, Belgium
  8. 8Centre Hospitalier Régional d’Orléans, and GINECO, France
  9. 9Centre Hospitalier Départemental Les Oudairies, and GINECO, France
  10. 10GH Saint Joseph, and GINECO, France
  11. 11Centre Paul Strauss, and GINECO, France
  12. 12AstraZeneca, UK


Introduction In the Phase III PAOLA-1/ENGOT-ov25 trial (NCT02477644), adding maintenance olaparib to bevacizumab improved progression-free survival (PFS) in patients with advanced ovarian cancer in response after first-line platinum-based chemotherapy plus bevacizumab (HR 0.59; 95% CI 0.49–0.72) (Ray-Coquard et al. NEJM 2019). Outcomes in patients classified by clinical risk according to biomarker status are unknown.

Methods Patients were classified as higher-risk (stage III patients with upfront surgery and residual disease or who received neoadjuvant chemotherapy, or stage IV patients) or lower-risk (stage III patients with upfront surgery and no residual disease). This exploratory analysis evaluated PFS in higher-risk and lower-risk patients, including by biomarker status: homologous recombination deficiency (HRD)-positive, HRD-negative/unknown and tumour BRCA mutation (BRCAm)-positive.

Results Of 806 randomized patients, 74% were higher risk and 26% were lower risk, with median follow-up of 22.4 and 23.8 months, respectively. PFS significantly favoured olaparib plus bevacizumab versus placebo plus bevacizumab in higher-risk and lower-risk patients. In both higher- and lower-risk patients, the greatest PFS benefit was seen with olaparib plus bevacizumab versus bevacizumab alone in the HRD-positive subgroup (figures 1 and 2) and the subgroup with a tumour BRCAm (figure 2). Outcomes in the higher- and lower-risk HRD-negative/unknown subgroups are shown in figure 2.

Abstract 18 Figure 1

Kaplan-Meier estimates of investigator-assessed PFS in higher-risk and lower-risk HRD-positive patients*

Abstract 18 Figure 2

Analysis of investigator-assessed PFS in higher-risk* and lower-risk† patients, including in biomarker subgroups

Conclusions In PAOLA-1, maintenance olaparib plus bevacizumab provided a substantial PFS benefit over bevacizumab alone in higher-risk and lower-risk patients, especially in the HRD-positive and BRCAm populations.

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