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Mini Oral session

36MO - 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

Date

24 Feb 2023

Session

Mini Oral session

Topics

Tumour Site

Ovarian Cancer

Presenters

Antonio Jose Gonzalez Martin

Citation

Annals of Oncology (2023) 8 (1suppl_1): 100811-100811. 10.1016/esmoop/esmoop100811

Authors

A.J. Gonzalez Martin1, J. Medioni2, P. Harter3, C. Cropet4, S. Cinieri5, U. Denison6, H. Fujiwara7, I.B. Vergote8, A. Bologna9, S. Hietanen10, M.J. Rodrigues11, L.C. Hanker12, C. Zamagni13, S. Hernando Polo14, D. Bello Roufai15, D. Bauerschlag16, B. You17, P. Hillemanns18, E. Pujade-Lauraine19, I.L. Ray-Coquard20

Author affiliations

  • 1 Clinica Universidad de Navarra, Madrid/ES
  • 2 Hôpital Européen Georges Pompidou, and GINECO, Paris/FR
  • 3 Kliniken Essen-Mitte, and AGO, Essen/DE
  • 4 Centre Léon Bérard, and GINECO, Lyon/FR
  • 5 Ospedale Senatore Antonio Perrino, and MITO, Brindisi/IT
  • 6 Institute for Gynaecological Oncology und Senology - Karl Landsteiner, Klinik Hietzing, and AGO AU, Vienna/AT
  • 7 Jichi Medical University, and GOTIC, Tochigi/JP
  • 8 UZ Leuven - University Hospitals Leuven - Campus Gasthuisberg, Leuven/BE
  • 9 IRCCS di Reggio Emilia, and MANGO, Reggio Emilia/IT
  • 10 Turku University Hospital, and NSGO, Turku/FI
  • 11 Institut Curie - Hopital Claudius Régaud, and GINECO, Paris/FR
  • 12 Universitätsklinikum Schleswig-Holstein, Universitätfrauenklinik, Campus Lübeck, and AGO, Lübeck/DE
  • 13 IRCCS Azienda Ospedaliero-Universitaria di Bologna, and MITO, 40138 - Bologna/IT
  • 14 Fundación Hospital de Alcorcón, and GEICO, Madrid/ES
  • 15 Institut Curie - Saint-Cloud, and GINECO, Paris/FR
  • 16 University Medical Center Schleswig-Holstein, UKSH, and AGO, 24105 - Campus Kiel/DE
  • 17 HCL – Centre Hospitalier Lyon Sud, and GINECO, Pierre-Bénite/FR
  • 18 Dedizinische Hochschule Hannover, and AGO, Hannover/DE
  • 19 ARCAGY Research, and GINECO, Paris/FR
  • 20 Centre Léon Bérard, Lyon/FR

Resources

This content is available to ESMO members and event participants.

Abstract 36MO

Background

The first-line setting represents the only opportunity for cure in advanced OC. 5-y PFS rates may predict cure as most pts not relapsing at 5 years are potentially cured. In the final overall survival (OS) analysis of the Phase III PAOLA-1/ENGOT-ov25 trial (NCT02477644), maintenance olaparib + bev provided a clinically meaningful OS benefit vs placebo (pbo) + bev in pts with newly diagnosed advanced OC who tested positive for homologous recombination deficiency (HRD+; tumour BRCA1/2 mutation [tBRCAm] and/or genomic instability) regardless of tBRCAm status (Ray-Coquard et al. Ann Oncol 2022:LBA29). We evaluated 5-y PFS by molecular subgroup to help inform the potential for cure.

Methods

Pts in response after platinum-based chemotherapy + bev were randomized 2:1 to olaparib (300 mg bid for up to 24 months) + bev (15 mg/kg q3w for up to 15 months) or pbo + bev. A post hoc, updated descriptive PFS analysis by molecular subgroup was conducted at the final OS data cutoff (DCO).

Results

537 pts were randomized to olaparib + bev and 269 to pbo + bev (median PFS follow-up in censored pts was 56.7 and 57.8 months, respectively). At DCO (22 March 2022), the 5-y PFS rate was 46% with olaparib + bev vs 19% with pbo + bev in the HRD+ group, 50% vs 25%, respectively, in the tBRCAm group, 41% vs 15%, respectively, in the HRD+ excluding tBRCAm group, 13% vs 13%, respectively, in the HRD−/unknown group, and 8% vs 12%, respectively, in the HRD− group. Updated data for time to first or second subsequent therapy or death will be presented.Table: 36MO
Figure 1

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 trial identification

NCT02477644.

Editorial acknowledgement

Medical writing assistance was provided by Abbie Newman BSc, at Cence, funded by AstraZeneca and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Legal entity responsible for the study

ARCAGY Research.

Funding

ARCAGY Research, AstraZeneca, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and F. Hoffmann-La Roche.

Disclosure

A.J. Gonzalez Martin: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Clovis, GSK, Genmab, Alkermes, Sutro, Roche, SOTIO, PharmaMar, Oncoinvent, Novartis, Mersana, MSD, Macrogenics, Eisai, ImmunoGen, Regeneron, HederaDx, Illumina; Financial Interests, Personal, Invited Speaker: GSK, AstraZeneca, Clovis, Roche, Novocure, MSD, Takeda, Zaylab; Financial Interests, Institutional, Invited Speaker, PI of ANITA trial: GSK, Roche; Financial Interests, Personal, Invited Speaker, Member of ENGOT ov43-SC: MSD; Financial Interests, Institutional, Invited Speaker, ENGOT PI of EPIK-O trial: Novartis; Financial Interests, Institutional, Invited Speaker, ENGOT PI of AVB-500 phase III trial: ARAVIVE. J. Medioni: Financial Interests, Personal, Advisory Board: Daiichi Sankyo, Gilead, Lilly-Eli; Non-Financial Interests, Personal, Other, Travelling facilities: Pfizer. P. Harter: Financial Interests, Personal, Advisory Board, Value includes honoraria for lectures: AstraZeneca; Financial Interests, Personal, Advisory Board, includes honoraria for lectures: GSK, Roche, MSD; Financial Interests, Personal, Invited Speaker: Amgen, Stryker, Zailab, Eisai; Financial Interests, Personal, Advisory Board: Clovis, Immunogen, Novartis, Mersana; Financial Interests, Personal, Other, IDMC member: Sotio; Financial Interests, Institutional, Invited Speaker: AstraZeneca, Roche, GSK, Genmab, Immunogen; Financial Interests, Institutional, Funding: Seagen, Clovis; Non-Financial Interests, Personal, Principal Investigator: AstraZeneca. S. Cinieri: Financial Interests, Institutional, Other: Lilly Oncology. I.B. Vergote: Financial Interests, Personal, Advisory Board, Consulting: Agenus (2021), Aksebio China (2021), AstraZeneca (2021-2022), Bristol Myers Squibb (2021), Deciphera Pharmaceuticals (2021), Eisai (2021), F. Hoffmann-La Roche Ltd (2021), Genmab (2021), GSK (2021), Immunogen Inc. (2021-2022), Jazzpharma (2021-2022), Karyopharm (2021), MSD (2021-2022), Novocure (2020-2022), Novartis (2021), Oncoinvent AS (2021-2022), Seagen (2021), Sotio a.s. (2021-2022); Financial Interests, Institutional, Advisory Board, Consulting: AstraZeneca (2019-2020), Deciphera Pharmaceuticals (2020), Elevar Therapeutics (2020), F. Hoffmann-La Roche Ltd (2019-2020), Genmab (2019-2020), GSK (2019-2020), Mersana (2020), MSD (2019-2020), Oncoinvent AS (2019-2020), Sotio a.s. (2019-2020), Verastem Oncology (2020), Zentalis (2020), Amgen (Europe) 2019, Clovis Oncology Inc (2019), Carrick Therapeutics (2019), Millennium Pharmaceuticals (2019); Financial Interests, Institutional, Research Grant, Contracted Research (via KU Leuven): Oncoinvent AS (2019-2020); Financial Interests, Institutional, Research Grant, Contracted Research (via KU Leuven): Genmab (2019); Financial Interests, Institutional, Research Grant, Corporate sponsored research: Amgen (2019-2020), Roche (2019-2020). S. Hietanen: Financial Interests, Personal, Advisory Board: AstraZeneca, GSK, MSD. M.J. Rodrigues: Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, GSK, Immunocore; Financial Interests, Personal, Research Grant: MSD, BMS. L.C. Hanker: Financial Interests, Personal, Advisory Board: Amgen, Roche, GSK, MSD, AstraZeneca. C. Zamagni: Financial Interests, Personal and Institutional, Research Grant: Roche, Novartis, AstraZeneca, Pfizer, Tesaro, Pierre Fabre, 1st. Gentili, Teva, Seagen; Financial Interests, Personal, Research Grant: Eisai, PharmaMar, Eli Lilly, Celgene, MSD, GSK, Amgen, Daiichi Sankyoi; Financial Interests, Personal, Advisory Board: Roche, Eisai, Novartis, AstraZeneca, Pfizer, PharmaMar, Tesaro, QuintikesIMS, Eli Lilly, Celegene, MSD, GSK, Daiichi Sankyo; Financial Interests, Personal, Other, Other financial or non-financial interests: Roche, Novartis, AstraZeneca, Pfizer, Amgen, Tesaro, QuintikesIMS, MSD, GSK, Daiichi Sankyo. S. Hernando Polo: Financial Interests, Institutional, Full or part-time Employment: Hospital Universitario Fundacion Alcorcón; Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, GSK, Pfizer, Clovis. D. Bauerschlag: Financial Interests, Personal, Advisory Board: AstraZeneca. B. You: Financial Interests, Personal, Advisory Board: MSD, AstraZeneca, GSK-TESARO, Bayer, Roche-Genentech, ECS Progastrine, Novartis, LEK, Amgen, Clovis Oncology, Merck Serono, BMS, Seagen, Myriad. P. Hillemanns: Financial Interests, Personal, Invited Speaker, Lecture Fee: Roche, MSD, AstraZeneca. E. Pujade-Lauraine: Financial Interests, Personal, Advisory Board: Roche, GSK, AstraZeneca; Financial Interests, Personal, Member, IDMC board: Agenus, Incyte; Financial Interests, Personal, Full or part-time Employment: ARCAGY. I.L. Ray-Coquard: Financial Interests, Personal, Advisory Board: Roche, GSK, AstraZeneca, Mersana, Deciphera, Amgen, Oxnea, Merck Sereno, Agenus, Novartis, Macrogenics, Clovis, EQRX, Adaptimmune, Eisai, SUTRO, BMS, Adaptimmune, Daiichi Sankyo; Financial Interests, Institutional, Other, COLIBRI translational research: BMS; Financial Interests, Institutional, Advisory Board, translational research NEOPREMBROV trial: MSD; Non-Financial Interests, Personal, Principal Investigator: PAOLA1; Non-Financial Interests, Personal, Other, President: GINECO. All other authors have declared no conflicts of interest.

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