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  • #525 Impact of BRCA mutation status on efficacy of atezolizumab combined with platinum-based chemotherapy and maintenance niraparib for late-relapsing recurrent ovarian cancer: subgroup analysis of the ENGOT-Ov41/GEICO 69-O/ANITA phase 3 trial

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Late Breaking Abstracts
06. Ovarian Cancer
#525 Impact of BRCA mutation status on efficacy of atezolizumab combined with platinum-based chemotherapy and maintenance niraparib for late-relapsing recurrent ovarian cancer: subgroup analysis of the ENGOT-Ov41/GEICO 69-O/ANITA phase 3 trial
  1. Frédéric Selle1,
  2. Maria Jesús Rubio2,
  3. Stefan Kommoss3,
  4. Rossella Franzini4,
  5. Toon Van Gorp5,
  6. Ana Oaknin6,
  7. Philippe Follana7,
  8. Margarita Romeo8,
  9. Michel Fabbro9,
  10. Lydia Gaba10,
  11. Jean-Pierre Lotz11,
  12. Luis Miguel De Sande12,
  13. Andres Redondo13,
  14. Maria-Pilar Barretina-Ginesta14,
  15. Alejandro Pérez-Fidalgo15,
  16. Ana Santaballa16,
  17. Mª José Bermejo Pérez17,
  18. Annamaria Ferrero18,
  19. Manuel Rodrigues19 and
  20. Antonio González-Martín20
  1. 1GINECO and Groupe Hospitalier Diaconesses Croix Saint Simon, Paris, France
  2. 2GEICO and Reina Sofia University Hospital of Córdoba, Córdoba, Spain
  3. 3AGO Study Group and Diakonie-Klinikum Schwäbisch Hall gGmbH, Schwäbisch Hall, Germany
  4. 4MaNGO and Spedali Civili di Brescia, Brescia, Italy
  5. 5BGOG and University Hospital Leuven Leuven Cancer Institute, Leuven, Belgium
  6. 6GEICO and Medical Oncology Service, Vall d’Hebron Institute of Oncology, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
  7. 7GINECO and Centre Antoine Lacassagne, Nice, France
  8. 8GEICO and Institut Català d’Oncologia Badalona, Badalona, Spain
  9. 9GINECO and Institut du Cancer de Montpellier Val d’Aurelle, Montpellier, France
  10. 10GEICO and Medical Oncology Department Hospital Clinic and Translational Genomics and Targeted Therapies in Solid Tumors, IDIBAPS, Barcelona, Spain
  11. 11Hôpital Tenon, Assistance Publique, Paris, France
  12. 12GEICO and Complejo Asistencial Universitario de León, León, Spain
  13. 13GEICO and Hospital Universitario La Paz-IdiPAZ, Madrid, Spain
  14. 14GEICO and Department of Medical Oncology, Catalan Institute of Oncology, Oncogir-Pro IDIBGI, Girona, Spain
  15. 15GEICO and INCLIVA, Biomedical Research Institute, Hospital Clínico Universitario, University of Valencia, Valencia, Spain
  16. 16GEICO, La Fe University Hospital, Valencia, Spain
  17. 17GEICO and Medical Oncology Intercenter Unit. Regional and Virgen de la Victoria University Hospitals. IBIMA, Málaga, Spain
  18. 18MaNGO and Ospedale Mauriziano di Torino, University of Torino, Turin, Italy
  19. 19GINECO and Institut Curie, Paris, France
  20. 20GEICO and Cancer Center Clínica Universidad de Navarra (CCUN), Madrid, Spain

Abstract

Introduction/Background Primary results from the ANITA (NCT03598270) phase 3 trial in patients with late-relapsing recurrent ovarian cancer showed no progression-free survival (PFS) improvement with the addition of atezolizumab to platinum-based chemotherapy and maintenance niraparib in the intent-to-treat population [González-Martín ESMO 2023]. Subgroup analyses of PFS suggested divergent effects according to BRCA mutation status.

Methodology Patients with measurable high-grade serous, endometrioid or undifferentiated recurrent ovarian cancer, 1–2 prior chemotherapy lines and a platinum-free interval (TFIp) >6 months were randomised 1:1 to a carboplatin doublet plus either atezolizumab (1200 mg every 3 weeks or equivalent) or placebo for 6 cycles, followed (in patients without progression) by maintenance niraparib with continued atezolizumab or placebo until disease progression. Stratification factors were investigator-selected carboplatin doublet, TFIp, BRCA status and PD-L1 status. Efficacy according to BRCA mutation status was a secondary endpoint.

Results BRCA mutations were detected in 63 (15%; germline 10%, somatic 5%) of 417 randomised patients, with some imbalances in baseline characteristics between treatment arms (table 1). Compared with the BRCA-non-mutated population, the BRCA-mutated population included more patients with prior PARP inhibitor (PARPi) exposure and/or TFIp >12 months. In the BRCA-mutated subgroup, median PFS, objective response rate (ORR) and median maintenance PFS numerically favoured atezolizumab-containing therapy, whereas hazard ratios favoured the standard arm.

Conclusion The BRCA-mutated subgroup showed a higher ORR and longer median PFS and maintenance PFS with atezolizumab-containing therapy versus chemotherapy and niraparib alone, but with unfavourable hazard ratios. The small patient numbers in this subgroup limit interpretation and may contribute to the apparent discordance.

Disclosures Study drug and funding for this investigator-initiated study are provided by F. Hoffmann-La Roche and GSK.

FS reports honoraria/consultation fees for advisory boards from AstraZeneca, GSK/Tesaro and MSD and for invited speaker engagements from AstraZeneca, GSK/Tesaro, MSD and Eisai.

MJR has no potential conflicts to report.

SK has no potential conflicts to report.

RF has no potential conflicts to report.

TVG reports grants/research support from Amgen, Roche and AstraZeneca, honoraria/consultation fees from AstraZeneca, Eisai, GSK, ImmunoGen, Incyte, Karyopharm, MSD, OncXerna, Seagen, Tubulis and Zentalis, participation in company-sponsored speaker’s bureau for AstraZeneca, GSK, ImmunoGen and MSD and travel/accommodation/expenses from AstraZeneca, GSK, ImmunoGen, MSD and PharmaMar.

AO reports honoraria/consultation fees from Agenus, AstraZeneca, Clovis Oncology, Corcept Therapeutics, Deciphera Pharmaceuticals, Eisai, Exelisis, EMD Serono, F. Hoffmann-La Roche, Genmab, GSK, ImmunoGen, Itheos, Merck Sharps & Dohme Spain, Mersana Therapeutics, Novocure, OneXerna Therapeutics, Inc., PharmaMar, Regeneron, Sattucklabs, Seagen and Sutro Biopharma and personal fees for travel/accommodation from AstraZeneca, PharmaMar and Roche.

PF reports honoraria/consultation fees from AstraZeneca, MSD, GSK, Daiichi-Sankyo, Novartis, Lilly and Eisai.

MR reports honoraria/consultation fees from GSK, AstraZeneca and MSD and travel grants from MSD.

MF reports honoraria/consultation fees from GSK.

LG reports grants/research support, honoraria/consultation fees and meeting/travel support from GSK, MSD, AstraZeneca, PharmaMar and Clovis Oncology.

J-PL has no potential conflicts to report.

LMdSG has no potential conflicts to report.

AR reports honoraria/consultation fees from AstraZeneca, GSK, MSD, Eisai and PharmaMar and participation in company-sponsored speaker’s bureau for AstraZeneca, GSK and MSD.

M-PB-G reports honoraria/consultation fees and participation in company-sponsored speaker’s bureau for AstraZeneca, Clovis, GSK, MSD, PharmaMar and Roche and travel and expenses from AstraZeneca, Clovis, GSK and MSD.

AP-F reports grants/research supports from GSK, AstraZeneca and PharmaMar, honoraria/consultation fees from GSK, AstraZeneca, Ability Pharma, PharmaMar, Eisai, MSD and Clovis and participation in company-sponsored speaker’s bureau for GSK, AstraZeneca, PharmaMar, MSD and Clovis.

AS reports honoraria/consultation fees from MSD, AstraZeneca, Pharma&, GSK, Lilly, Novartis and Pfizer and participation in company-sponsored speaker’s bureau for MSD, AstraZeneca, GSK, Lilly and Pfizer.

MJB reports participation in company-sponsored speaker’s bureau for AstraZeneca, GSK and MSD.

AF reports honoraria/consultation fees from AstraZeneca, MSD and GSK.

MR reports grants/research support from MSD and Janssen-Cilag and honoraria/consultation fees for advisory boards from AstraZeneca, GSK/Tesaro and MSD.

AG-M reports honoraria/consultation fees from Alkermes, Amgen, AstraZeneca, Clovis, Genmab, GSK, Hedera Dx, Immunogen, Kartos, Karyopharm, Illumina, Mersana, MSD, Novartis, Novocure, Oncoinvent, PharmaMar, Roche, SOTIO, SUTRO, Seagen, Takeda and Tubulis, participation in company-sponsored speaker’s bureau for AstraZeneca, Clovis, GSK, Immunogen, Mersana, MSD, Novocure, PharmaMar, Roche and Takeda and grants/research supports from GSK, Roche, ISCIII and AECC.

View this table:
Abstract #525 Table 1

Baseline characteristics and outcomes according to BRCA mutation status and treatment

https://doi.org/10.1136/ijgc-2024-ESGO.1119

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