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#928 Subgroup analysis by chemotherapy regimen in the ENGOT-Ov41/GEICO 69-O/ANITA phase 3 trial evaluating atezolizumab combined with a platinum doublet and maintenance niraparib for late-relapsing ovarian cancer
  1. Florian Heitz1,2,
  2. Beatriz Pardo3,
  3. Renaud Sabatier4,
  4. Nicoletta Colombo5,
  5. Stéphanie Henry6,
  6. Gloria Marquina7,
  7. Florence Joly8,
  8. María Quindós9,
  9. Laura Mansi10,
  10. Purificación Estévez-García11,
  11. Jean-Sebastien Frenel12,
  12. Eva Guerra13,
  13. Luis Manso14,
  14. Victoria Casado15,
  15. Luisa Sánchez-Lorenzo16,
  16. Mª Eugenia Ortega17,
  17. Delphine Duliège18,
  18. Frederik Marmé19,
  19. Elena García Martínez20 and
  20. Antonio Gonzalez Martín21
  1. 1AGO and Kliniken Essen-Mitte, Essen, Germany
  2. 2Department for Gynecology with the Center for Oncologic Surgery Charité Campus Virchow-Klinikum, Berlin, Germany
  3. 3GEICO and Institut Català d’Oncologia, Barcelona, Spain
  4. 4Hospital Duran i Reynals, Marseille, France
  5. 5IDIBELL, Milan, Italy
  6. 6L’Hospitalet de LLobregat, Namur, Belgium
  7. 7GINECO and Institut Paoli Calmettes, Madrid, Spain
  8. 8MaNGO and Gynecologic Oncology Department, Caen, France
  9. 9European Institute of Oncology IRCCS Milan, A Coruña, Spain
  10. 10and Department of Medicine and Surgery, Besançon, France
  11. 11University of Milan-Bicocca, Seville, Spain
  12. 12BGOG and Universite Catholique de Louvain, Saint Herblain, France
  13. 13CHU UCL NAMUR (site Ste Elisabeth), Madrid, Spain
  14. 14GEICO and Hospital Clínico San Carlos, Madrid, Spain
  15. 15GINECO and Centre François Baclesse, Madrid, Spain
  16. 16GEICO and A Coruña Biomedical Research Institute (INIBIC), Madrid, Spain
  17. 17A Coruña University Hospital, Zaragoza, Spain
  18. 18GINECO and CHU de Besançon – Hôpital Jean Minjoz, Nîmes, France
  19. 19GEICO and Hospital Universitario Virgen del Rocío and Instituto de Biomedicina de Sevilla, Mannheim, Germany
  20. 20GINECO and Institut de Cancerologie de L’Ouest, Murcia, Spain
  21. 21GEICO and Hospital Universitario Ramón y Cajal, Madrid, Spain
  22. 22Charité – Universitätsmedizin Berlin
  23. 23Corporate member of Freie Universität Berlin
  24. 24Humboldt-Universität zu Berlin
  25. 25and Berlin Institute of Health


Introduction/Background Immune checkpoint inhibitors have generally shown disappointing results in phase 3 trials in ovarian cancer and their role in combination with standard therapy is unclear; however, subgroup analyses have yielded unexpected results. We explored clinical outcomes according to investigator-selected chemotherapy in the ANITA (NCT03598270) phase 3 trial.

Methodology Eligible patients had measurable high-grade serous, endometrioid or undifferentiated ovarian cancer with first or second relapse >6 months after platinum-based chemotherapy. Standard therapy comprised an investigator-selected carboplatin doublet (paclitaxel, gemcitabine or pegylated liposomal doxorubicin [PLD]) for 6 cycles, followed by maintenance niraparib in patients with a complete or partial response or stable disease. Patients were randomised 1:1, stratified by carboplatin doublet, platinum treatment-free interval (TFIp), BRCA status and PD-L1 status (SP142 IHC assay), to receive either atezolizumab (1200 mg every 3 weeks or equivalent) or placebo throughout standard therapy. The primary endpoint was progression-free survival (PFS). Subgroup analyses according to carboplatin partner were prespecified.

Results In the gemcitabine subgroup, PFS favoured atezolizumab (hazard ratio 0.49, 95% CI 0.28–0.87). Similar effects were not observed in the PLD or paclitaxel subgroups (table 1). Patients in the gemcitabine subgroup were more heavily pretreated (with the highest frequency of prior PARP inhibition and 2 prior chemotherapy lines in the placebo group), received a lower median carboplatin dose (inherent in the protocol) and had shorter median PFS and lower objective response rate (ORR) than patients in the PLD or paclitaxel subgroups.

Conclusion The apparent difference in atezolizumab treatment effect according to investigator-selected chemotherapy doublet, including more favourable outcomes with atezolizumab in the gemcitabine subgroup, may be attributable to selection bias towards gemcitabine in poorer-prognosis patients and the small sample sizes of the paclitaxel and gemcitabine subgroups. Ongoing translational work may reveal further differences and hypotheses.

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

FH reports honoraria/consultation fees from Novocure, PharmaMar, AstraZeneca, Roche, Tesaro, GSK, Clovis, amedes, NEO NewOncology and Zai Lab.

BP reports honoraria/consultation fees from GSK, MSD, AstraZeneca, Clovis and PharmaMar, participation in company-sponsored speaker’s bureau for Clovis, PharmaMar, GSK and MSD and travel grants/attendance at scientific meetings from GSK, MSD, AstraZeneca and Clovis.

RS reports grants/research support from AstraZeneca, honoraria/consultation fees from GSK, Eisai and Seagen, participation in company-sponsored speaker’s bureau for Novartis, GSK, Eisai and Clovis Oncology and non-financial support from MSD, GSK and Novartis.

NC reports grants/research support from AstraZeneca, GSK and Roche, honoraria/consultation fees from AstraZeneca, Clovis, Eisai, GSK, Immunogen, Mersana, MSD, Nuvation BIO, OncXerna Therapeutics, Inc., Roche and Novocure and participation in company-sponsored speaker’s bureau for AstraZeneca, Clovis Oncology, GSK, MSD/Merck and Eisai.

SH reports honoraria/consultation fees from and participation in company-sponsored speaker’s bureau for AstraZeneca, Merck, Novartis, MSD Oncology, BMS, Sanofi, Gilead and GSK and travel/accommodation/expenses from Gilead, Roche, GSK and MSD Oncology.

GM reports honoraria/consultation fees and travel grants from Roche and GSK.

FJ reports honoraria/consultation fees from GSK, AstraZeneca, MSD, Eisai, Seagen and Novocure.

MQ has no potential conflicts of interest to report.

LMansi reports honoraria/consultation fees from Lilly, MSD, Novartis, Eisai, Pfizer and Roche, participation in company-sponsored speaker’s bureau for MSD and Roche and travel grant and scientific meeting attendance for Pfizer.

PE-G reports grants/research support from GSK and honoraria/consultation fees/participation in company-sponsored speaker’s bureau for GSK, Clovis, PharmaMar, AstraZeneca and MSD.

J-SF reports honoraria/consultation fees from AstraZeneca, Daiichi Sankyo, Pfizer, Lilly, Novartis, GSK, MSD, Eisai and Seagen.

EG reports honoraria/consultation fees and participation in company-sponsored speaker’s bureau for AstraZeneca-MSD, Clovis Oncology, GSK-Tesaro, PharmaMar and Roche.

LManso has no potential conflict of interest to report.

VC reports advisory board honoraria from AstraZeneca, GlaxoSmithKline, MSD and PharmaMar and speaker honoraria from AstraZeneca and MSD.

LS-L has no potential conflicts of interest to report.

MEO reports honoraria/consultation fees from Merck, MSD, GSK, AstraZeneca, Clovis, PharmaMar and Eisai.

DD has no potential conflicts of interest to report.

FM reports grants/research support from Roche, AstraZeneca, Novartis, Eisai, Gilead, MSD, Vaccibody, GSK, Lilly, Seagen and Daiichi Sankyo and honoraria/consultation fees from Roche, AstraZeneca, Gilead, MSD, GSK, Clovis, Novartis, Pfizer, Lilly, PharmaMar, Genomic Health, Myriad, Seagen, Daiichi Sankyo, Stemline and Menarini.

EGM has no potential conflicts of interest to report.

AGM 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.

Abstract #928 Table 1

Baseline characteristics, carboplatin exposure and outcomes according to chemotherapy regimen and treatment arm

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