PMID- 37643382
OWN - NLM
STAT- MEDLINE
DCOM- 20231127
LR  - 20231127
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 41
IP  - 30
DP  - 2023 Oct 20
TI  - Atezolizumab Combined With Bevacizumab and Platinum-Based Therapy for 
      Platinum-Sensitive Ovarian Cancer: Placebo-Controlled Randomized Phase III 
      ATALANTE/ENGOT-ov29 Trial.
PG  - 4768-4778
LID - 10.1200/JCO.23.00529 [doi]
AB  - PURPOSE: Platinum-based doublets with concurrent and maintenance bevacizumab are 
      standard therapy for ovarian cancer (OC) relapsing after a platinum-free interval 
      (PFI) >6 months. Immunotherapy may be synergistic with bevacizumab and 
      chemotherapy. PATIENTS AND METHODS: ATALANTE/ENGOT-ov29 (ClinicalTrials.gov 
      identifier: NCT02891824), a placebo-controlled double-blinded randomized phase 
      III trial, enrolled patients with recurrent epithelial OC, one to two previous 
      chemotherapy lines, and PFI >6 months. Eligible patients were randomly assigned 
      2:1 to atezolizumab (1,200 mg once every 3 weeks or equivalent) or placebo for up 
      to 24 months, combined with bevacizumab and six cycles of chemotherapy doublet, 
      stratified by PFI, PD-L1 status, and chemotherapy regimen. Coprimary end points 
      were investigator-assessed progression-free survival (PFS) in the 
      intention-to-treat (ITT) and PD-L1-positive populations (alpha .025 for each 
      population). RESULTS: Between September 2016 and October 2019, 614 patients were 
      randomly assigned: 410 to atezolizumab and 204 to placebo. Only 38% had 
      PD-L1-positive tumors. After 3 years' median follow-up, the PFS difference 
      between atezolizumab and placebo did not reach statistical significance in the 
      ITT (hazard ratio [HR], 0.83; 95% CI, 0.69 to 0.99; P = .041; median 13.5 v 11.3 
      months, respectively) or PD-L1-positive (HR, 0.86; 95% CI, 0.63 to 1.16; P = .30; 
      median 15.2 v 13.1 months, respectively) populations. The immature overall 
      survival (OS) HR was 0.81 (95% CI, 0.65 to 1.01; median 35.5 v 30.6 months with 
      atezolizumab v placebo, respectively). Global health-related quality of life did 
      not differ between treatment arms. Grade >/=3 adverse events (AEs) occurred in 88% 
      of atezolizumab-treated and 87% of placebo-treated patients; grade >/=3 AEs typical 
      of immunotherapy were more common with atezolizumab (13% v 8%, respectively). 
      CONCLUSION: ATALANTE/ENGOT-ov29 did not meet its coprimary PFS objectives in the 
      ITT or PD-L1-positive populations. OS follow-up continues. Further research on 
      biopsy samples is warranted to decipher the immunologic landscape of 
      late-relapsing OC.
FAU - Kurtz, Jean-Emmanuel
AU  - Kurtz JE
AUID- ORCID: 0000-0003-4611-5797
AD  - Department of Medical and Surgical Oncology & Hematology, ICANS, Strasbourg, 
      France.
FAU - Pujade-Lauraine, Eric
AU  - Pujade-Lauraine E
AUID- ORCID: 0000-0002-0759-7263
AD  - Association de Recherche sur les CAncers dont GYnecologiques (ARCAGY)-GINECO, 
      Paris, France.
FAU - Oaknin, Ana
AU  - Oaknin A
AUID- ORCID: 0000-0002-3592-7194
AD  - Gynaecologic Cancer Programme, Vall D'Hebron Institute of Oncology (VHIO), 
      Hospital Universitario Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, 
      Barcelona, Spain.
FAU - Belin, Lisa
AU  - Belin L
AD  - Biostatistics and Public Health Department, Sorbonne Universite, INSERM, Institut 
      Pierre Louis d'Epidemiologie et de Sante Publique, Assistance Publique - Hopitaux 
      de Paris, Hopitaux Universitaires Pitie Salpetriere - Charles Foix, Paris, 
      France.
FAU - Leitner, Katharina
AU  - Leitner K
AUID- ORCID: 0000-0002-9572-9114
AD  - Gynecology and Obstetrics Department, Medical University of Innsbruck, Innsbruck, 
      Austria.
FAU - Cibula, David
AU  - Cibula D
AUID- ORCID: 0000-0001-6387-9356
AD  - Department of Obstetrics and Gynecology, General University Hospital in Prague, 
      Charles University, Prague, Czech Republic.
FAU - Denys, Hannelore
AU  - Denys H
AUID- ORCID: 0000-0002-8897-9430
AD  - Department of Medical Oncology, University Hospital Ghent, Ghent, Belgium.
FAU - Rosengarten, Ora
AU  - Rosengarten O
AD  - Oncology Department, Shaare Zedek Medical Center, Jerusalem, Israel.
FAU - Rodrigues, Manuel
AU  - Rodrigues M
AUID- ORCID: 0000-0002-5443-0802
AD  - Department of Medical Oncology and INSERM U830, Institut Curie, PSL Research 
      University, Paris, France.
FAU - de Gregorio, Nikolaus
AU  - de Gregorio N
AD  - Department of Obstetrics and Gynaecology, University Hospital Ulm, Ulm, Germany.
AD  - SLK Klinikum Heilbronn, Heilbronn, Germany.
FAU - Martinez Garcia, Jeronimo
AU  - Martinez Garcia J
AUID- ORCID: 0000-0002-2295-5161
AD  - Medical Oncology Department, Hospital Universitario Virgen Arrixaca (El Palmar) 
      and Biomedical Research Institute of Murcia (IMIB), Murcia, Spain.
FAU - Petru, Edgar
AU  - Petru E
AD  - Department of Gynecology and Obstetrics, Division of Gynecology, Medical 
      University of Graz, Graz, Austria.
FAU - Kocian, Roman
AU  - Kocian R
AUID- ORCID: 0000-0002-5896-4158
AD  - Department of Obstetrics and Gynecology, General University Hospital in Prague, 
      Charles University, Prague, Czech Republic.
FAU - Vergote, Ignace
AU  - Vergote I
AUID- ORCID: 0000-0002-7589-8981
AD  - Department of Gynecology, University Hospitals Leuven, Leuven Cancer Institute, 
      Leuven, Belgium.
FAU - Pautier, Patricia
AU  - Pautier P
AD  - Department of Medicine, Gustave Roussy, Villejuif, France.
FAU - Schmalfeldt, Barbara
AU  - Schmalfeldt B
AD  - Department of Gynaecology and Gynaecologic Oncology, University Medical Centre 
      Hamburg-Eppendorf, Hamburg, Germany.
FAU - Gaba, Lydia
AU  - Gaba L
AUID- ORCID: 0000-0002-6898-0557
AD  - Department of Medical Oncology, Translational Genomics and Targeted Therapeutics 
      in Solid Tumors, Hospital Clinic de Barcelona, Institut D'Investigacions 
      Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.
FAU - Polterauer, Stephan
AU  - Polterauer S
AUID- ORCID: 0000-0002-9649-4505
AD  - Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, 
      Austria.
FAU - Mouret Reynier, Marie-Ange
AU  - Mouret Reynier MA
AD  - Oncology Department, Centre Jean Perrin, Clermont-Ferrand, France.
FAU - Sehouli, Jalid
AU  - Sehouli J
AD  - Department of Gynecology with Center for Oncological Surgery, 
      Charite-Universitatsmedizin Berlin, Corporate Member of Freie Universitat Berlin, 
      Humboldt-Universitat zu Berlin, Berlin, Germany.
AD  - Berlin Institute of Health, Charite Medical University, Berlin, Germany.
FAU - Churruca, Cristina
AU  - Churruca C
AD  - Department of Medical Oncology, Hospital Universitario Donostia, Donostia, Spain.
FAU - Selle, Frederic
AU  - Selle F
AD  - Oncology Department, Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, 
      France.
FAU - Joly, Florence
AU  - Joly F
AUID- ORCID: 0000-0001-7004-9895
AD  - Medical Oncology Department, Centre Francois Baclesse, Caen, France.
FAU - D'Hondt, Veronique
AU  - D'Hondt V
AUID- ORCID: 0000-0001-5238-4032
AD  - Medical Oncology Department, Institut Regional du Cancer Montpellier (ICM), 
      Montpellier, France.
FAU - Bultot-Boissier, Emilie
AU  - Bultot-Boissier E
AD  - Oncology Department, Assistance Publique - Hopitaux de Paris, Hopital Europeen 
      Georges Pompidou, Paris, France.
FAU - Lebreton, Coriolan
AU  - Lebreton C
AUID- ORCID: 0000-0002-4275-1721
AD  - Medical Oncology Department, Institut Bergonie, Bordeaux, France.
FAU - Lotz, Jean-Pierre
AU  - Lotz JP
AUID- ORCID: 0000-0003-1771-7051
AD  - Medical Oncology Service, Hopital Tenon, Hopitaux Universitaires de l'Est 
      Parisien, Assistance Publique - Hopitaux de Paris, Paris, France.
FAU - Largillier, Remy
AU  - Largillier R
AD  - Department of Medical Oncology, Centre Azureen de Cancerologie, Mougins, France.
FAU - Heudel, Pierre-Etienne
AU  - Heudel PE
AUID- ORCID: 0000-0002-2155-549X
AD  - Oncology Department, Centre Leon Berard, Lyon, France.
FAU - Heitz, Florian
AU  - Heitz F
AUID- ORCID: 0000-0002-2412-0352
AD  - Department of Gynecology with Center for Oncological Surgery, 
      Charite-Universitatsmedizin Berlin, Corporate Member of Freie Universitat Berlin, 
      Humboldt-Universitat zu Berlin, Berlin, Germany.
AD  - Berlin Institute of Health, Charite Medical University, Berlin, Germany.
AD  - Department of Gynecology and Gynecologic Oncology, Evangelische Kliniken 
      Essen-Mitte, Essen, Germany.
CN  - ATALANTE/ENGOT-ov29 Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT02891824
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20230829
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 52CMI0WC3Y (atezolizumab)
RN  - 0 (B7-H1 Antigen)
RN  - 2S9ZZM9Q9V (Bevacizumab)
RN  - 49DFR088MY (Platinum)
SB  - IM
MH  - Female
MH  - Humans
MH  - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
MH  - *B7-H1 Antigen/therapeutic use
MH  - Bevacizumab
MH  - Carcinoma, Ovarian Epithelial/drug therapy
MH  - Neoplasm Recurrence, Local/drug therapy
MH  - *Ovarian Neoplasms/drug therapy/pathology
MH  - Platinum/therapeutic use
MH  - Quality of Life
PMC - PMC10602539
COIS- The following represents disclosure information provided by authors of this 
      manuscript. All relationships are considered compensated unless otherwise noted. 
      Relationships are self-held unless noted. I = Immediate Family Member, Inst = My 
      Institution. Relationships may not relate to the subject matter of this 
      manuscript. For more information about ASCO's conflict of interest policy, please 
      refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center. Open 
      Payments is a public database containing information reported by companies about 
      payments made to US-licensed physicians (Open Payments). Florian Heitz Honoraria: 
      Roche, AstraZeneca, Tesaro/GSK Consulting or Advisory Role: Roche, AstraZeneca, 
      GlaxoSmithKline, Novocure, PharmaMar Research Funding: AstraZeneca (Inst), Amedes 
      (Inst) No other potential conflicts of interest were reported.
EDAT- 2023/08/29 18:41
MHDA- 2023/10/23 00:42
PMCR- 2023/08/29
CRDT- 2023/08/29 16:03
PHST- 2023/10/23 00:42 [medline]
PHST- 2023/08/29 18:41 [pubmed]
PHST- 2023/08/29 16:03 [entrez]
PHST- 2023/08/29 00:00 [pmc-release]
AID - JCO.23.00529 [pii]
AID - 10.1200/JCO.23.00529 [doi]
PST - ppublish
SO  - J Clin Oncol. 2023 Oct 20;41(30):4768-4778. doi: 10.1200/JCO.23.00529. Epub 2023 
      Aug 29.