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403 Primary results from ENGOT-Ov41/GEICO 69-O/ANITA, a double-blind placebo-controlled phase 3 trial evaluating atezolizumab combined with platinum-based chemotherapy and maintenance niraparib for recurrent ovarian cancer with a platinum-free interval >6 months
  1. Antonio González-Martín1,
  2. Maria Jesús Rubio-Pérez2,
  3. Florian Heitz3,
  4. René Depont Christensen4,
  5. Nicoletta Colombo5,
  6. Toon Van Gorp6,
  7. Ana Oaknin7,
  8. Alexandra Leary8,
  9. Lydia Gaba9,
  10. Coriolan Lebreton10,
  11. Luis Miguel De Sande González11,
  12. Margarita Romeo12,
  13. Andres Redondo13,
  14. Maria-Pilar Barretina-Ginesta14,
  15. Alejandro Pérez-Fidalgo15,
  16. Ana Santaballa16,
  17. María José Bermejo17,
  18. Ilan Bruchim18,
  19. Isabelle Ray-Coquard19 and
  20. Frédéric Selle20
  1. 1GEICO and Cima-Universidad de Navarra, Cancer Center Clínica Universidad de Navarra (CCUN), Madrid, Spain
  2. 2GEICO and Reina Sofia University Hospital of Córdoba, Córdoba, Spain
  3. 3AGO and Kliniken Essen-Mitte, Essen, Germany
  4. 4NSGO and GEICO, Copenhagen, Denmark
  5. 5MaNGO and Gynecologic Oncology Department, European Institute of Oncology IRCCS Milan, and Department of Medicine and Surgery, University of Milan-Bicocca, Milan, Italy
  6. 6BGOG and University Hospital Leuven, Leuven Cancer Institute, Leuven, Belgium
  7. 7GEICO and Medical Oncology Service, Vall d’Hebron Institute of Oncology, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
  8. 8GINECO and Cancer Medicine Department, Institut de Cancérologie Gustave Roussy, Villejuif, France
  9. 9GEICO and Medical Oncology Department Hospital Clinic and Translational Genomics and Targeted Therapies in Solid Tumors, IDIBAPS, Barcelona, Spain
  10. 10GINECO and Institut Bergonié, Bordeaux, France
  11. 11GEICO and Complejo Asistencial Universitario de León, León, Spain
  12. 12GEICO and Institut Català d’Oncologia Badalona, Badalona, Spain
  13. 13GEICO and Hospital Universitario La Paz-IdiPAZ, Madrid, Spain
  14. 14GEICO and Catalan Institute of Oncology, IDIBGI, Girona, Spain
  15. 15GEICO and INCLIVA, Biomedical Research Institute, Hospital Clínico Universitario, University of Valencia, Valencia, Spain
  16. 16GEICO and Hospital Universitario La Fe, Valencia, Spain
  17. 17GEICO and Medical Oncology Intercenter Unit, Regional and Virgen de la Victoria University Hospitals, IBIMA, Málaga, Spain
  18. 18ISGO and Hillel Yaffe Medical Center Israel, affiliated with the Ruth and Bruce Rappaport Faculty of Medicine, Technion – Israel Institute of Technology, Haifa, Israel
  19. 19GINECO and Centre Léon Bérard and University of Lyon, Lyon, France
  20. 20GINECO and Hospital Diaconesses-Croix St Simon, Paris, France


Introduction/Background Standard therapy for recurrent ovarian cancer (rOC) with a platinum-free interval (TFIp) >6 months includes PARPi maintenance if disease responds to platinum-based chemotherapy. ANITA (NCT03598270) evaluated combining atezolizumab with platinum-based chemotherapy and maintenance PARPi in this population.

Methodology Eligible patients had measurable high-grade serous, endometrioid or undifferentiated rOC, ≤2 prior lines of chemotherapy (most recent including platinum) and TFIp >6 months. Prior PARPi for rOC and/or prior immune checkpoint inhibitor were prohibited. Patients were stratified by carboplatin doublet (paclitaxel, gemcitabine or PLD), TFIp (6–12 vs >12 months), BRCA status (mutated vs non-mutated) and PD-L1 status (PD-L1-expressing immune cells on <1% vs ≥1% tumour area vs non-informative by SP142). Patients were randomised 1:1 to a carboplatin doublet plus atezolizumab/placebo for 6 cycles, followed (in patients without progression on chemotherapy) by maintenance niraparib at an individualised starting dose plus atezolizumab/placebo until disease progression. The atezolizumab dose was 1200 mg q3w or equivalent. The primary endpoint was investigator-assessed progression-free survival (PFS) per RECIST v1.1.

Results Between November 2018 and January 2022, 417 patients were randomised (14% BRCA-mutated, 36% PD-L1-positive, 66% TFIp >12 months, 11% prior PARPi after front-line chemotherapy, 54% prior bevacizumab); most (71%) received carboplatin+PLD. At the data cut-off (15 April 2023), median follow-up was 36 months. PFS was not significantly improved with the addition of atezolizumab overall or in most subgroups (figure 1). Overall response rates (ORRs) were 45% (95% CI 39–52%) with atezolizumab+chemotherapy and 43% (95% CI 36–49%) with placebo+chemotherapy. In 306 patients (73%) who received maintenance, PFS from initiating maintenance numerically favoured atezolizumab+niraparib vs placebo+niraparib (hazard ratio 0.80, 95% CI 0.62–1.03; median 6.7 vs 5.3 months; not statistically significant). The safety profile was as expected from prior experience of these drugs.

Conclusion Combining atezolizumab with chemotherapy and maintenance niraparib for late-relapsing rOC did not significantly improve PFS, ORR or maintenance PFS.

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

AGM reports grants/research support from GSK, Roche, ISCiii and AECC, honoraria/consultation fees from Alkermes, Amgen, AstraZeneca, Clovis, Genmab, GSK, HederaDx, Immunogen, Kartos, Karyopharm, Illumina, Mersana, MSD, Novartis, Novocure, Oncoinvent, PharmaMar, Roche, SOTIO, SUTRO, Seagen, Takeda and Tubulis, and participation in company-sponsored speaker’s bureau for AstraZeneca, Clovis, GSK, Immunogen, Mersana, MSD, Novocure, PharmaMar, Roche and Takeda. Disclosures for coauthors have been provided separately.

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