ATHENA (GOG-3020/ENGOT-ov45): a randomized, phase III trial to evaluate rucaparib as monotherapy (ATHENA–MONO) and rucaparib in combination with nivolumab (ATHENA–COMBO) as maintenance treatment following frontline platinum-based chemotherapy in ovarian cancer

BackgroundThe optimal treatment strategy for women with newly diagnosed ovarian cancer has yet to be determined. Poly(ADP-ribose) polymerase (PARP) inhibitors have demonstrated substantial improvement in progression-free survival as monotherapy maintenance treatment in the frontline setting versus a...

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Vydané v:	International journal of gynecological cancer Ročník 31; číslo 12; s. 1589 - 1594
Hlavní autori:	Monk, Bradley J, Coleman, Robert L, Fujiwara, Keiichi, Wilson, Michelle K, Oza, Amit M, Oaknin, Ana, O’Malley, David M, Lorusso, Domenica, Westin, Shannon N, Safra, Tamar, Herzog, Thomas J, Marmé, Frederik, N Eskander, Ramez, Lin, Kevin K, Shih, Danny, Goble, Sandra, Grechko, Nikolay, Hume, Stephanie, Maloney, Lara, McNeish, Iain A, Kristeleit, Rebecca S
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	United States BMJ Publishing Group Ltd 01.12.2021 Elsevier Inc by the International Gynecologic Cancer Society and the European Society of Gynaecological Oncology BMJ Publishing Group
Predmet:	Antineoplastic Combined Chemotherapy Protocols - administration & dosage BRCA1 protein BRCA2 protein Carcinoma, Ovarian Epithelial - drug therapy Clinical Trial Double-Blind Method Female homologous recombination Humans Indoles - administration & dosage Maintenance Chemotherapy - methods Nivolumab - administration & dosage ovarian neoplasms Ovarian Neoplasms - drug therapy Poly(ADP-ribose) Polymerase Inhibitors - administration & dosage BRCA2 protein ovarian neoplasms homologous recombination BRCA1 protein
ISSN:	1048-891X, 1525-1438, 1525-1438
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Abstract	BackgroundThe optimal treatment strategy for women with newly diagnosed ovarian cancer has yet to be determined. Poly(ADP-ribose) polymerase (PARP) inhibitors have demonstrated substantial improvement in progression-free survival as monotherapy maintenance treatment in the frontline setting versus active surveillance. Furthermore, preclinical and early clinical studies have shown that PARP inhibitors and immune checkpoint inhibitors have synergistic antitumor activity and may provide an additional therapeutic option for patients in this population.Primary ObjectivesIn women with newly diagnosed ovarian, fallopian tube, or peritoneal cancer, we wish to assess the efficacy of frontline maintenance treatment with the PARP inhibitor rucaparib versus placebo following response to platinum-based chemotherapy (ATHENA–MONO), and to assess the combination of rucaparib plus nivolumab (a programmed death receptor 1 (PD-1)–blocking monoclonal antibody) versus rucaparib alone (ATHENA–COMBO).Study Hypothesis(1) Maintenance therapy with rucaparib monotherapy may extend progression-free survival following standard treatment for ovarian cancer in the frontline setting. (2) The combination of nivolumab plus rucaparib may extend progression-free survival following standard treatment for ovarian cancer in the frontline setting compared with rucaparib alone.Trial DesignATHENA is an international, randomized, double-blind, phase III trial consisting of two independent comparisons (ATHENA–MONO and ATHENA–COMBO) in patients with newly diagnosed platinum-sensitive ovarian cancer. Patients are randomized 4:4:1:1 to the following: oral rucaparib+ intravenous nivolumab (arm A); oral rucaparib + intravenous placebo (arm B); oral placebo+ intravenous nivolumab (arm C); and oral placebo + intravenous placebo (arm D). The starting dose of rucaparib is 600 mg orally twice a day and nivolumab 480 mg intravenously every 4 weeks. ATHENA–MONO compares arm B with arm D to evaluate rucaparib monotherapy versus placebo, and ATHENA–COMBO evaluates arm A versus arm B to investigate the effects of rucaparib and nivolumab in combination versus rucaparib monotherapy. ATHENA–MONO and ATHENA–COMBO share a common treatment arm (arm B) but each comparison is independently powered.Major Inclusion/Exclusion CriteriaPatients ≥18 years of age with newly diagnosed advanced, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer who have achieved a response after completion of cytoreductive surgery and initial platinum-based chemotherapy are enrolled. No other prior treatment for ovarian cancer, other than the frontline platinum regimen, is permitted.Primary EndpointThe primary endpoint is investigator-assessed progression-free survival by Response Evaluation Criteria in Solid Tumors v1.1.Sample SizeApproximately 1000 patients have been enrolled and randomized.Estimated Dates for Completing Accrual and Presenting ResultsThe trial completed accrual in 2020. While dependent on event rates, primary results of ATHENA–MONO are anticipated in early 2022 and results of ATHENA–COMBO are anticipated to mature at a later date.Trial RegistrationThis trial is registered at clinicaltrials.gov (NCT03522246).
AbstractList	The optimal treatment strategy for women with newly diagnosed ovarian cancer has yet to be determined. Poly(ADP-ribose) polymerase (PARP) inhibitors have demonstrated substantial improvement in progression-free survival as monotherapy maintenance treatment in the frontline setting versus active surveillance. Furthermore, preclinical and early clinical studies have shown that PARP inhibitors and immune checkpoint inhibitors have synergistic antitumor activity and may provide an additional therapeutic option for patients in this population.BACKGROUNDThe optimal treatment strategy for women with newly diagnosed ovarian cancer has yet to be determined. Poly(ADP-ribose) polymerase (PARP) inhibitors have demonstrated substantial improvement in progression-free survival as monotherapy maintenance treatment in the frontline setting versus active surveillance. Furthermore, preclinical and early clinical studies have shown that PARP inhibitors and immune checkpoint inhibitors have synergistic antitumor activity and may provide an additional therapeutic option for patients in this population.In women with newly diagnosed ovarian, fallopian tube, or peritoneal cancer, we wish to assess the efficacy of frontline maintenance treatment with the PARP inhibitor rucaparib versus placebo following response to platinum-based chemotherapy (ATHENA-MONO), and to assess the combination of rucaparib plus nivolumab (a programmed death receptor 1 (PD-1)-blocking monoclonal antibody) versus rucaparib alone (ATHENA-COMBO).PRIMARY OBJECTIVESIn women with newly diagnosed ovarian, fallopian tube, or peritoneal cancer, we wish to assess the efficacy of frontline maintenance treatment with the PARP inhibitor rucaparib versus placebo following response to platinum-based chemotherapy (ATHENA-MONO), and to assess the combination of rucaparib plus nivolumab (a programmed death receptor 1 (PD-1)-blocking monoclonal antibody) versus rucaparib alone (ATHENA-COMBO).(1) Maintenance therapy with rucaparib monotherapy may extend progression-free survival following standard treatment for ovarian cancer in the frontline setting. (2) The combination of nivolumab plus rucaparib may extend progression-free survival following standard treatment for ovarian cancer in the frontline setting compared with rucaparib alone.STUDY HYPOTHESIS(1) Maintenance therapy with rucaparib monotherapy may extend progression-free survival following standard treatment for ovarian cancer in the frontline setting. (2) The combination of nivolumab plus rucaparib may extend progression-free survival following standard treatment for ovarian cancer in the frontline setting compared with rucaparib alone.ATHENA is an international, randomized, double-blind, phase III trial consisting of two independent comparisons (ATHENA-MONO and ATHENA-COMBO) in patients with newly diagnosed platinum-sensitive ovarian cancer. Patients are randomized 4:4:1:1 to the following: oral rucaparib+ intravenous nivolumab (arm A); oral rucaparib + intravenous placebo (arm B); oral placebo+ intravenous nivolumab (arm C); and oral placebo + intravenous placebo (arm D). The starting dose of rucaparib is 600 mg orally twice a day and nivolumab 480 mg intravenously every 4 weeks. ATHENA-MONO compares arm B with arm D to evaluate rucaparib monotherapy versus placebo, and ATHENA-COMBO evaluates arm A versus arm B to investigate the effects of rucaparib and nivolumab in combination versus rucaparib monotherapy. ATHENA-MONO and ATHENA-COMBO share a common treatment arm (arm B) but each comparison is independently powered.TRIAL DESIGNATHENA is an international, randomized, double-blind, phase III trial consisting of two independent comparisons (ATHENA-MONO and ATHENA-COMBO) in patients with newly diagnosed platinum-sensitive ovarian cancer. Patients are randomized 4:4:1:1 to the following: oral rucaparib+ intravenous nivolumab (arm A); oral rucaparib + intravenous placebo (arm B); oral placebo+ intravenous nivolumab (arm C); and oral placebo + intravenous placebo (arm D). The starting dose of rucaparib is 600 mg orally twice a day and nivolumab 480 mg intravenously every 4 weeks. ATHENA-MONO compares arm B with arm D to evaluate rucaparib monotherapy versus placebo, and ATHENA-COMBO evaluates arm A versus arm B to investigate the effects of rucaparib and nivolumab in combination versus rucaparib monotherapy. ATHENA-MONO and ATHENA-COMBO share a common treatment arm (arm B) but each comparison is independently powered.Patients ≥18 years of age with newly diagnosed advanced, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer who have achieved a response after completion of cytoreductive surgery and initial platinum-based chemotherapy are enrolled. No other prior treatment for ovarian cancer, other than the frontline platinum regimen, is permitted.MAJOR INCLUSION/EXCLUSION CRITERIAPatients ≥18 years of age with newly diagnosed advanced, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer who have achieved a response after completion of cytoreductive surgery and initial platinum-based chemotherapy are enrolled. No other prior treatment for ovarian cancer, other than the frontline platinum regimen, is permitted.The primary endpoint is investigator-assessed progression-free survival by Response Evaluation Criteria in Solid Tumors v1.1.PRIMARY ENDPOINTThe primary endpoint is investigator-assessed progression-free survival by Response Evaluation Criteria in Solid Tumors v1.1.Approximately 1000 patients have been enrolled and randomized.SAMPLE SIZEApproximately 1000 patients have been enrolled and randomized.The trial completed accrual in 2020. While dependent on event rates, primary results of ATHENA-MONO are anticipated in early 2022 and results of ATHENA-COMBO are anticipated to mature at a later date.ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTSThe trial completed accrual in 2020. While dependent on event rates, primary results of ATHENA-MONO are anticipated in early 2022 and results of ATHENA-COMBO are anticipated to mature at a later date.This trial is registered at clinicaltrials.gov (NCT03522246).TRIAL REGISTRATIONThis trial is registered at clinicaltrials.gov (NCT03522246). The optimal treatment strategy for women with newly diagnosed ovarian cancer has yet to be determined. Poly(ADP-ribose) polymerase (PARP) inhibitors have demonstrated substantial improvement in progression-free survival as monotherapy maintenance treatment in the frontline setting versus active surveillance. Furthermore, preclinical and early clinical studies have shown that PARP inhibitors and immune checkpoint inhibitors have synergistic antitumor activity and may provide an additional therapeutic option for patients in this population. In women with newly diagnosed ovarian, fallopian tube, or peritoneal cancer, we wish to assess the efficacy of frontline maintenance treatment with the PARP inhibitor rucaparib versus placebo following response to platinum-based chemotherapy (ATHENA-MONO), and to assess the combination of rucaparib plus nivolumab (a programmed death receptor 1 (PD-1)-blocking monoclonal antibody) versus rucaparib alone (ATHENA-COMBO). (1) Maintenance therapy with rucaparib monotherapy may extend progression-free survival following standard treatment for ovarian cancer in the frontline setting. (2) The combination of nivolumab plus rucaparib may extend progression-free survival following standard treatment for ovarian cancer in the frontline setting compared with rucaparib alone. ATHENA is an international, randomized, double-blind, phase III trial consisting of two independent comparisons (ATHENA-MONO and ATHENA-COMBO) in patients with newly diagnosed platinum-sensitive ovarian cancer. Patients are randomized 4:4:1:1 to the following: oral rucaparib+ intravenous nivolumab (arm A); oral rucaparib + intravenous placebo (arm B); oral placebo+ intravenous nivolumab (arm C); and oral placebo + intravenous placebo (arm D). The starting dose of rucaparib is 600 mg orally twice a day and nivolumab 480 mg intravenously every 4 weeks. ATHENA-MONO compares arm B with arm D to evaluate rucaparib monotherapy versus placebo, and ATHENA-COMBO evaluates arm A versus arm B to investigate the effects of rucaparib and nivolumab in combination versus rucaparib monotherapy. ATHENA-MONO and ATHENA-COMBO share a common treatment arm (arm B) but each comparison is independently powered. Patients ≥18 years of age with newly diagnosed advanced, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer who have achieved a response after completion of cytoreductive surgery and initial platinum-based chemotherapy are enrolled. No other prior treatment for ovarian cancer, other than the frontline platinum regimen, is permitted. The primary endpoint is investigator-assessed progression-free survival by Response Evaluation Criteria in Solid Tumors v1.1. Approximately 1000 patients have been enrolled and randomized. The trial completed accrual in 2020. While dependent on event rates, primary results of ATHENA-MONO are anticipated in early 2022 and results of ATHENA-COMBO are anticipated to mature at a later date. This trial is registered at clinicaltrials.gov (NCT03522246). BackgroundThe optimal treatment strategy for women with newly diagnosed ovarian cancer has yet to be determined. Poly(ADP-ribose) polymerase (PARP) inhibitors have demonstrated substantial improvement in progression-free survival as monotherapy maintenance treatment in the frontline setting versus active surveillance. Furthermore, preclinical and early clinical studies have shown that PARP inhibitors and immune checkpoint inhibitors have synergistic antitumor activity and may provide an additional therapeutic option for patients in this population.Primary ObjectivesIn women with newly diagnosed ovarian, fallopian tube, or peritoneal cancer, we wish to assess the efficacy of frontline maintenance treatment with the PARP inhibitor rucaparib versus placebo following response to platinum-based chemotherapy (ATHENA–MONO), and to assess the combination of rucaparib plus nivolumab (a programmed death receptor 1 (PD-1)–blocking monoclonal antibody) versus rucaparib alone (ATHENA–COMBO).Study Hypothesis(1) Maintenance therapy with rucaparib monotherapy may extend progression-free survival following standard treatment for ovarian cancer in the frontline setting. (2) The combination of nivolumab plus rucaparib may extend progression-free survival following standard treatment for ovarian cancer in the frontline setting compared with rucaparib alone.Trial DesignATHENA is an international, randomized, double-blind, phase III trial consisting of two independent comparisons (ATHENA–MONO and ATHENA–COMBO) in patients with newly diagnosed platinum-sensitive ovarian cancer. Patients are randomized 4:4:1:1 to the following: oral rucaparib+ intravenous nivolumab (arm A); oral rucaparib + intravenous placebo (arm B); oral placebo+ intravenous nivolumab (arm C); and oral placebo + intravenous placebo (arm D). The starting dose of rucaparib is 600 mg orally twice a day and nivolumab 480 mg intravenously every 4 weeks. ATHENA–MONO compares arm B with arm D to evaluate rucaparib monotherapy versus placebo, and ATHENA–COMBO evaluates arm A versus arm B to investigate the effects of rucaparib and nivolumab in combination versus rucaparib monotherapy. ATHENA–MONO and ATHENA–COMBO share a common treatment arm (arm B) but each comparison is independently powered.Major Inclusion/Exclusion CriteriaPatients ≥18 years of age with newly diagnosed advanced, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer who have achieved a response after completion of cytoreductive surgery and initial platinum-based chemotherapy are enrolled. No other prior treatment for ovarian cancer, other than the frontline platinum regimen, is permitted.Primary EndpointThe primary endpoint is investigator-assessed progression-free survival by Response Evaluation Criteria in Solid Tumors v1.1.Sample SizeApproximately 1000 patients have been enrolled and randomized.Estimated Dates for Completing Accrual and Presenting ResultsThe trial completed accrual in 2020. While dependent on event rates, primary results of ATHENA–MONO are anticipated in early 2022 and results of ATHENA–COMBO are anticipated to mature at a later date.Trial RegistrationThis trial is registered at clinicaltrials.gov (NCT03522246).
ArticleNumber	ijgc-2021-002933
Author	Monk, Bradley J O’Malley, David M Oaknin, Ana N Eskander, Ramez Wilson, Michelle K Grechko, Nikolay Fujiwara, Keiichi Hume, Stephanie McNeish, Iain A Coleman, Robert L Marmé, Frederik Shih, Danny Westin, Shannon N Oza, Amit M Goble, Sandra Herzog, Thomas J Lin, Kevin K Maloney, Lara Lorusso, Domenica Safra, Tamar Kristeleit, Rebecca S
AuthorAffiliation	Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, Arizona, USA US Oncology Research, The Woodlands, Texas, USA Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan Department of Cancer and Blood, Auckland City Hospital, Auckland, New Zealand Division of Medical Oncology and Hematology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada Medical Oncology Department, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain Division of Gynecologic Oncology, The Ohio State University, James Cancer Center, Columbus, Ohio, USA Unità di Ginecologia Oncologica, Fondazione IRCCS Istituto Nazionale dei Tumori and MITO, MIlan, Italy Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA Oncology Department, Tel Aviv Sourask
AuthorAffiliation_xml	– name: Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, Arizona, USA US Oncology Research, The Woodlands, Texas, USA Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan Department of Cancer and Blood, Auckland City Hospital, Auckland, New Zealand Division of Medical Oncology and Hematology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada Medical Oncology Department, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain Division of Gynecologic Oncology, The Ohio State University, James Cancer Center, Columbus, Ohio, USA Unità di Ginecologia Oncologica, Fondazione IRCCS Istituto Nazionale dei Tumori and MITO, MIlan, Italy Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA Oncology Department, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel Department of Ob/Gyn, University of Cincinnati Cancer Center, Cincinnati, Ohio, USA Gynecological Oncology, National Center for Tumor Diseases (NCT) Heidelberg, Heidelberg, Germany Department of Obstetrics, Gynecology, and Reproductive Sciences, Division of Gynecologic Oncology, Rebecca and John Moores Cancer Center, University of California San Diego, La Jolla, California, USA Molecular Diagnostics, Clovis Oncology, Inc, Boulder, Colorado, USA Clinical Operations, Clovis Oncology, Inc, Boulder, Colorado, USA Biostatistics, Clovis Oncology, Inc, Boulder, Colorado, USA Clinical Development, Clovis Oncology, Ltd, Cambridge, Cambridgeshire, UK Clinical Development, Clovis Oncology, Inc, Boulder, Colorado, USA Department of Surgery and Cancer, Imperial College London, London, UK Department of Oncology, Guy’s and St Thomas’ NHS Foundation Trust, London, UK – name: 3 Department of Gynecologic Oncology , Saitama Medical University International Medical Center , Hidaka , Saitama , Japan – name: 9 Department of Gynecologic Oncology and Reproductive Medicine , The University of Texas MD Anderson Cancer Center , Houston , Texas , USA – name: 16 Biostatistics , Clovis Oncology, Inc , Boulder , Colorado , USA – name: 18 Clinical Development , Clovis Oncology, Inc , Boulder , Colorado , USA – name: 13 Department of Obstetrics, Gynecology, and Reproductive Sciences, Division of Gynecologic Oncology, Rebecca and John Moores Cancer Center , University of California San Diego , La Jolla , California , USA – name: 12 Gynecological Oncology , National Center for Tumor Diseases (NCT) Heidelberg , Heidelberg , Germany – name: 15 Clinical Operations , Clovis Oncology, Inc , Boulder , Colorado , USA – name: 17 Clinical Development , Clovis Oncology, Ltd , Cambridge , Cambridgeshire , UK – name: 4 Department of Cancer and Blood , Auckland City Hospital , Auckland , New Zealand – name: 5 Division of Medical Oncology and Hematology , Princess Margaret Hospital Cancer Centre , Toronto , Ontario , Canada – name: 10 Oncology Department, Tel Aviv Sourasky Medical Center, Sackler School of Medicine , Tel Aviv University , Tel Aviv , Israel – name: 14 Molecular Diagnostics , Clovis Oncology, Inc , Boulder , Colorado , USA – name: 11 Department of Ob/Gyn , University of Cincinnati Cancer Center , Cincinnati , Ohio , USA – name: 19 Department of Surgery and Cancer , Imperial College London , London , UK – name: 20 Department of Oncology , Guy’s and St Thomas’ NHS Foundation Trust , London , UK – name: 2 US Oncology Research , The Woodlands , Texas , USA – name: 8 Unità di Ginecologia Oncologica , Fondazione IRCCS Istituto Nazionale dei Tumori and MITO , MIlan , Italy – name: 1 Arizona Oncology (US Oncology Network) , University of Arizona College of Medicine, Creighton University School of Medicine , Phoenix , Arizona , USA – name: 7 Division of Gynecologic Oncology , The Ohio State University, James Cancer Center , Columbus , Ohio , USA – name: 6 Medical Oncology Department , Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO) , Barcelona , Spain
Author_xml	– sequence: 1 givenname: Bradley J surname: Monk fullname: Monk, Bradley J email: bradley.monk@usoncology.com organization: Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, Arizona, USA – sequence: 2 givenname: Robert L surname: Coleman fullname: Coleman, Robert L organization: US Oncology Research, The Woodlands, Texas, USA – sequence: 3 givenname: Keiichi orcidid: 0000-0002-7388-0243 surname: Fujiwara fullname: Fujiwara, Keiichi organization: Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan – sequence: 4 givenname: Michelle K surname: Wilson fullname: Wilson, Michelle K organization: Department of Cancer and Blood, Auckland City Hospital, Auckland, New Zealand – sequence: 5 givenname: Amit M surname: Oza fullname: Oza, Amit M organization: Division of Medical Oncology and Hematology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada – sequence: 6 givenname: Ana surname: Oaknin fullname: Oaknin, Ana organization: Medical Oncology Department, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain – sequence: 7 givenname: David M surname: O’Malley fullname: O’Malley, David M organization: Division of Gynecologic Oncology, The Ohio State University, James Cancer Center, Columbus, Ohio, USA – sequence: 8 givenname: Domenica surname: Lorusso fullname: Lorusso, Domenica organization: Unità di Ginecologia Oncologica, Fondazione IRCCS Istituto Nazionale dei Tumori and MITO, MIlan, Italy – sequence: 9 givenname: Shannon N orcidid: 0000-0002-1922-0156 surname: Westin fullname: Westin, Shannon N organization: Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA – sequence: 10 givenname: Tamar surname: Safra fullname: Safra, Tamar organization: Oncology Department, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel – sequence: 11 givenname: Thomas J surname: Herzog fullname: Herzog, Thomas J organization: Department of Ob/Gyn, University of Cincinnati Cancer Center, Cincinnati, Ohio, USA – sequence: 12 givenname: Frederik surname: Marmé fullname: Marmé, Frederik organization: Gynecological Oncology, National Center for Tumor Diseases (NCT) Heidelberg, Heidelberg, Germany – sequence: 13 givenname: Ramez surname: N Eskander fullname: N Eskander, Ramez organization: Department of Obstetrics, Gynecology, and Reproductive Sciences, Division of Gynecologic Oncology, Rebecca and John Moores Cancer Center, University of California San Diego, La Jolla, California, USA – sequence: 14 givenname: Kevin K surname: Lin fullname: Lin, Kevin K organization: Molecular Diagnostics, Clovis Oncology, Inc, Boulder, Colorado, USA – sequence: 15 givenname: Danny surname: Shih fullname: Shih, Danny organization: Clinical Operations, Clovis Oncology, Inc, Boulder, Colorado, USA – sequence: 16 givenname: Sandra surname: Goble fullname: Goble, Sandra organization: Biostatistics, Clovis Oncology, Inc, Boulder, Colorado, USA – sequence: 17 givenname: Nikolay surname: Grechko fullname: Grechko, Nikolay organization: Clinical Development, Clovis Oncology, Ltd, Cambridge, Cambridgeshire, UK – sequence: 18 givenname: Stephanie surname: Hume fullname: Hume, Stephanie organization: Clinical Development, Clovis Oncology, Inc, Boulder, Colorado, USA – sequence: 19 givenname: Lara surname: Maloney fullname: Maloney, Lara organization: Clinical Development, Clovis Oncology, Inc, Boulder, Colorado, USA – sequence: 20 givenname: Iain A surname: McNeish fullname: McNeish, Iain A organization: Department of Surgery and Cancer, Imperial College London, London, UK – sequence: 21 givenname: Rebecca S surname: Kristeleit fullname: Kristeleit, Rebecca S organization: Department of Oncology, Guy’s and St Thomas’ NHS Foundation Trust, London, UK
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/34593565$$D View this record in MEDLINE/PubMed
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ContentType	Journal Article
Copyright	IGCS and ESGO 2021. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ. 2021 IGCS and ESGO 2021. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ. by the International Gynecologic Cancer Society and the European Society of Gynaecological Oncology. IGCS and ESGO 2021. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ. 2021
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Keywords	BRCA2 protein ovarian neoplasms homologous recombination BRCA1 protein
Language	English
License	This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, an indication of whether changes were made, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. http://creativecommons.org/licenses/by-nc-nd/4.0 IGCS and ESGO 2021. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.
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Notes	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 Present affiliation: The present affiliation of Frederik Marmé is: Department of Obstetrics and Gynecology, Medical Faculty Mannheim, Heidelberg University, University Hospital Mannheim, Mannheim, Germany
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References_xml	– volume: 39 start-page: 1842 year: 2021 ident: R12 article-title: Atezolizumab, bevacizumab, and chemotherapy for newly diagnosed stage III or IV ovarian cancer: placebo-controlled randomized phase III trial (IMagyn050/GOG 3015/ENGOT-OV39) publication-title: J Clin Oncol doi: 10.1200/JCO.21.00306 – volume: 381 start-page: 2416 year: 2019 ident: R7 article-title: Olaparib plus bevacizumab as first-line maintenance in ovarian cancer publication-title: N Engl J Med doi: 10.1056/NEJMoa1911361 – volume: 381 start-page: 2391 year: 2019 ident: R15 article-title: Niraparib in patients with newly diagnosed advanced ovarian cancer publication-title: N Engl J Med doi: 10.1056/NEJMoa1910962 – volume: 365 start-page: 2484 year: 2011 ident: R3 article-title: A phase 3 trial of bevacizumab in ovarian cancer publication-title: N Engl J Med doi: 10.1056/NEJMoa1103799 – volume: 152 start-page: 53 year: 2019 ident: R4 article-title: Exploratory outcome analyses according to stage and/or residual disease in the ICON7 trial of carboplatin and paclitaxel with or without bevacizumab for newly diagnosed ovarian cancer publication-title: Gynecol Oncol doi: 10.1016/j.ygyno.2018.08.036 – volume: 390 start-page: 1949 year: 2017 ident: R9 article-title: Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial publication-title: Lancet doi: 10.1016/S0140-6736(17)32440-6 – volume: 159 start-page: 13 year: 2020 ident: R11 article-title: Avelumab in combination with and/or following chemotherapy vs chemotherapy alone in patients with previously untreated epithelial ovarian cancer: results from the phase 3 JAVELIN ovarian 100 trial publication-title: Gynecol Oncol doi: 10.1016/j.ygyno.2020.06.025 – volume: 7 start-page: 13587 year: 2016 ident: R13 article-title: Association and prognostic significance of BRCA1/2-mutation status with neoantigen load, number of tumor-infiltrating lymphocytes and expression of PD-1/PD-L1 in high grade serous ovarian cancer publication-title: Oncotarget doi: 10.18632/oncotarget.7277 – volume: 37 start-page: 2317 year: 2019 ident: R5 article-title: Final overall survival of a randomized trial of bevacizumab for primary treatment of ovarian cancer publication-title: J Clin Oncol doi: 10.1200/JCO.19.01009 – volume: 365 start-page: 2473 year: 2011 ident: R2 article-title: Incorporation of bevacizumab in the primary treatment of ovarian cancer publication-title: N Engl J Med doi: 10.1056/NEJMoa1104390 – volume: 379 start-page: 2495 year: 2018 ident: R6 article-title: Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer publication-title: N Engl J Med doi: 10.1056/NEJMoa1810858 – volume: 381 start-page: 2416 year: 2019 end-page: 28 ident: bb0040 article-title: Olaparib plus bevacizumab as first-line maintenance in ovarian cancer publication-title: N Engl J Med – year: 2020 ident: bb0055 – volume: 37 start-page: 2317 year: 2019 end-page: 28 ident: bb0030 article-title: Final overall survival of a randomized trial of bevacizumab for primary treatment of ovarian cancer publication-title: J Clin Oncol – volume: 390 start-page: 1949 year: 2017 end-page: 61 ident: bb0050 article-title: Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial publication-title: Lancet – volume: 7 start-page: 13587 year: 2016 end-page: 98 ident: bb0070 article-title: Association and prognostic significance of BRCA1/2-mutation status with neoantigen load, number of tumor-infiltrating lymphocytes and expression of PD-1/PD-L1 in high grade serous ovarian cancer publication-title: Oncotarget – year: 2020 ident: bb0045 – year: 2021 ident: bb0075 publication-title: Association of BRCA1/2, homologous recombination deficiency, and PD-L1 with clinical outcomes in patients receiving atezolizumab versus placebo combined with carboplatin, paclitaxel, and bevacizumab for newly diagnosed ovarian cancer: exploratory analyses. Presented at: 2021 Society of Gynecologic Oncology (SGO) 2021 Virtual Annual Meeting – volume: 381 start-page: 2391 year: 2019 end-page: 402 ident: bb0080 article-title: Niraparib in patients with newly diagnosed advanced ovarian cancer publication-title: N Engl J Med – volume: 379 start-page: 2495 year: 2018 end-page: 505 ident: bb0035 article-title: Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer publication-title: N Engl J Med – year: 2020 ident: bb0010 – volume: 39 start-page: 1842 year: 2021 end-page: 55 ident: bb0065 article-title: Atezolizumab, bevacizumab, and chemotherapy for newly diagnosed stage III or IV ovarian cancer: placebo-controlled randomized phase III trial (IMagyn050/GOG 3015/ENGOT-OV39) publication-title: J Clin Oncol – volume: 365 start-page: 2473 year: 2011 end-page: 83 ident: bb0015 article-title: Incorporation of bevacizumab in the primary treatment of ovarian cancer publication-title: N Engl J Med – volume: 152 start-page: 53 year: 2019 end-page: 60 ident: bb0025 article-title: Exploratory outcome analyses according to stage and/or residual disease in the ICON7 trial of carboplatin and paclitaxel with or without bevacizumab for newly diagnosed ovarian cancer publication-title: Gynecol Oncol – volume: 365 start-page: 2484 year: 2011 end-page: 96 ident: bb0020 article-title: A phase 3 trial of bevacizumab in ovarian cancer publication-title: N Engl J Med – volume: 159 start-page: 13 year: 2020 end-page: 14 ident: bb0060 article-title: Avelumab in combination with and/or following chemotherapy vs chemotherapy alone in patients with previously untreated epithelial ovarian cancer: results from the phase 3 JAVELIN ovarian 100 trial publication-title: Gynecol Oncol – volume: 159 start-page: 13 year: 2020 ident: 10.1136/ijgc-2021-002933_bb0060 article-title: Avelumab in combination with and/or following chemotherapy vs chemotherapy alone in patients with previously untreated epithelial ovarian cancer: results from the phase 3 JAVELIN ovarian 100 trial publication-title: Gynecol Oncol doi: 10.1016/j.ygyno.2020.06.025 – year: 2020 ident: 10.1136/ijgc-2021-002933_bb0055 – volume: 381 start-page: 2391 year: 2019 ident: 10.1136/ijgc-2021-002933_bb0080 article-title: Niraparib in patients with newly diagnosed advanced ovarian cancer publication-title: N Engl J Med doi: 10.1056/NEJMoa1910962 – volume: 39 start-page: 1842 year: 2021 ident: 10.1136/ijgc-2021-002933_bb0065 article-title: Atezolizumab, bevacizumab, and chemotherapy for newly diagnosed stage III or IV ovarian cancer: placebo-controlled randomized phase III trial (IMagyn050/GOG 3015/ENGOT-OV39) publication-title: J Clin Oncol doi: 10.1200/JCO.21.00306 – year: 2020 ident: 10.1136/ijgc-2021-002933_bb0010 – year: 2020 ident: 10.1136/ijgc-2021-002933_bb0045 – volume: 7 start-page: 13587 year: 2016 ident: 10.1136/ijgc-2021-002933_bb0070 article-title: Association and prognostic significance of BRCA1/2-mutation status with neoantigen load, number of tumor-infiltrating lymphocytes and expression of PD-1/PD-L1 in high grade serous ovarian cancer publication-title: Oncotarget doi: 10.18632/oncotarget.7277 – volume: 365 start-page: 2473 year: 2011 ident: 10.1136/ijgc-2021-002933_bb0015 article-title: Incorporation of bevacizumab in the primary treatment of ovarian cancer publication-title: N Engl J Med doi: 10.1056/NEJMoa1104390 – volume: 365 start-page: 2484 year: 2011 ident: 10.1136/ijgc-2021-002933_bb0020 article-title: A phase 3 trial of bevacizumab in ovarian cancer publication-title: N Engl J Med doi: 10.1056/NEJMoa1103799 – volume: 381 start-page: 2416 year: 2019 ident: 10.1136/ijgc-2021-002933_bb0040 article-title: Olaparib plus bevacizumab as first-line maintenance in ovarian cancer publication-title: N Engl J Med doi: 10.1056/NEJMoa1911361 – volume: 390 start-page: 1949 year: 2017 ident: 10.1136/ijgc-2021-002933_bb0050 article-title: Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial publication-title: Lancet doi: 10.1016/S0140-6736(17)32440-6 – year: 2021 ident: 10.1136/ijgc-2021-002933_bb0075 – volume: 152 start-page: 53 year: 2019 ident: 10.1136/ijgc-2021-002933_bb0025 article-title: Exploratory outcome analyses according to stage and/or residual disease in the ICON7 trial of carboplatin and paclitaxel with or without bevacizumab for newly diagnosed ovarian cancer publication-title: Gynecol Oncol doi: 10.1016/j.ygyno.2018.08.036 – volume: 37 start-page: 2317 year: 2019 ident: 10.1136/ijgc-2021-002933_bb0030 article-title: Final overall survival of a randomized trial of bevacizumab for primary treatment of ovarian cancer publication-title: J Clin Oncol doi: 10.1200/JCO.19.01009 – volume: 379 start-page: 2495 year: 2018 ident: 10.1136/ijgc-2021-002933_bb0035 article-title: Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer publication-title: N Engl J Med doi: 10.1056/NEJMoa1810858
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Snippet	BackgroundThe optimal treatment strategy for women with newly diagnosed ovarian cancer has yet to be determined. Poly(ADP-ribose) polymerase (PARP) inhibitors... The optimal treatment strategy for women with newly diagnosed ovarian cancer has yet to be determined. Poly(ADP-ribose) polymerase (PARP) inhibitors have...
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SubjectTerms	Antineoplastic Combined Chemotherapy Protocols - administration & dosage BRCA1 protein BRCA2 protein Carcinoma, Ovarian Epithelial - drug therapy Clinical Trial Double-Blind Method Female homologous recombination Humans Indoles - administration & dosage Maintenance Chemotherapy - methods Nivolumab - administration & dosage ovarian neoplasms Ovarian Neoplasms - drug therapy Poly(ADP-ribose) Polymerase Inhibitors - administration & dosage
Title	ATHENA (GOG-3020/ENGOT-ov45): a randomized, phase III trial to evaluate rucaparib as monotherapy (ATHENA–MONO) and rucaparib in combination with nivolumab (ATHENA–COMBO) as maintenance treatment following frontline platinum-based chemotherapy in ovarian cancer
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