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Poster display session

264TiP - ENGOT-ov43/KEYLYNK-001: A phase III trial of pembrolizumab plus chemotherapy with olaparib maintenance for first-line treatment of BRCA¬-nonmutated advanced epithelial ovarian cancer

Date

23 Nov 2019

Session

Poster display session

Topics

Tumour Site

Ovarian Cancer

Presenters

Keiichi Fujiwara

Citation

Annals of Oncology (2019) 30 (suppl_9): ix77-ix90. 10.1093/annonc/mdz426

Authors

K. Fujiwara1, I.B. Vergote2, J. Sehouli3, V. Salutari4, P. Zola5, R. Madry6, R.M. Wenham7, J. Korach8, P. Pautier9, D. Cibula10, S. Lheureux11, K. Hasegawa12, B. Kim13, C. Lai14, A. Gonzalez-Martinez15, Q. Liu16, S.M. Keefe17, M. Puglisi18, S. Topuz19

Author affiliations

  • 1 Department Of Gynecologic Oncology, Saitama Medical University, 350-1298 - Saitama/JP
  • 2 Department Of Gynecology, University Hospitals Leuven - Campus Gasthuisberg, 3000 - Leuven/BE
  • 3 Department Of Gynecology, Universitätsklinik Charité, Campus Virchow Klinikum, 13353 - Berlin/DE
  • 4 Gynecology Oncology Unit, Policlinico Universitario A. Gemelli, 00168 - Rome/IT
  • 5 Department Of Surgical Sciences, University of Turin, Turin/IT
  • 6 Clinical Hospital Of The Transfiguration, University of Medical Sciences, 61-569 - Poznan/PL
  • 7 Department Of Gynecologic Oncology, Moffitt Cancer Center, Tampa/US
  • 8 Gynecologic Oncology, Chaim Sheba Medical Center, 52621 - Ramat Gan/IL
  • 9 Medecine, Gustave Roussy, 94805 - Villejuif/FR
  • 10 Gynaecological Cancers, Charles University First Faculty of Medicine Department of Oncology, 128 08 - Prague/CZ
  • 11 Cancer Clinical Research Unit, Princess Margaret Cancer Center, M5G 2M9 - Toronto/CA
  • 12 Gynecologic Oncology, Saitama Medical University International Medical Center, 350-1298 - Saitama/JP
  • 13 Department Of Obstetrics And Gynecology, Samsung Medical Center Sungkyunkwan University School of Medicine, 135-710 - Seoul/KR
  • 14 Department Of Gynecology And Obstetrics, Linkou Chang Gung Memorial Hospital, Taipei/TW
  • 15 Geico, Clinica Universidad de Navarra, Pamplona (Navarra)/ES
  • 16 Statistics, Merck & Co., Inc., Kenilworth/US
  • 17 Late Stage Oncology Clinical Development, Merck & Co., Inc., NJ 08889 - Kenilworth/US
  • 18 Clinical Development (oncology), Merck & Co., Inc., Kenilworth/US
  • 19 Gynecology And Obstetrics, Istanbul Medical Faculty Hospital, Istanbul/TR

Resources

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Abstract 264TiP

Background

Epithelial ovarian cancer (EOC) is the most lethal gynecologic cancer and is often diagnosed at advanced stages. The current standard of care (SOC) for advanced EOC is primary debulking surgery (PDS) followed by adjuvant carboplatin/paclitaxel chemotherapy (CT). Although SOC may be effective initially, most patients experience relapse within 3 years after treatment. Combination therapy with PD-1 inhibitor pembrolizumab (pembro) plus PARP inhibitor niraparib resulted in efficacy in patients with platinum-resistant, relapsed OC in the phase 1/2 study TOPACIO/KEYNOTE-162. The PARP inhibitor olaparib is approved for women with newly diagnosed BRCA-mutated OC, as well as for platinum-sensitive, recurrent OC regardless of BRCA1/2 status. Pembro plus CT followed by olaparib maintenance therapy is being investigated in ENGOT-ov43/KEYLYNK-001 (NCT03740165), a phase 3, randomized, double-blind, active- and placebo-controlled study for first-line treatment of women with BRCA1/2-nonmutated advanced EOC.

Trial design

Women with stage III or IV BRCA-nonmutated EOC, primary peritoneal cancer, or fallopian tube cancer will be randomized 1:1:1 after one lead-in cycle of CT to receive pembro + CT followed by olaparib maintenance; pembro + CT followed by placebo; or placebo + CT followed by placebo. Stratification factors include surgery status (residual tumor after PDS [yes/no] or planned interval debulking), planned bevacizumab use (yes/no), and PD-L1 combined positive score (CPS; <10 or ≥ 10). Pembro 200 mg Q3W will be administered for 35 infusions and CT will be administered for 5 cycles. Twice-daily olaparib 300 mg maintenance therapy will start after the end of CT as concomitant treatment with pembro for 2 years if the patient has a complete response or until discontinuation. Bevacizumab use is determined at the investigator’s discretion before randomization. Primary endpoints are investigator-assessed PFS per RECIST 1.1 criteria and OS. Key secondary endpoints are PFS assessed per RECIST 1.1 by blinded independent central review, PFS after next-line treatment, and safety. Enrollment is currently ongoing.

Clinical trial identification

NCT03740165.

Legal entity responsible for the study

Merck & Co., Inc.

Funding

Funding for this study was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Disclosure

K. Fujiwara: Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Chugai Pharma; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Eisai; Advisory / Consultancy, Research grant / Funding (institution): Merck Sharpe & Dohme Corp.; Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Taiho Pharmaceutical; Advisory / Consultancy: Takeda; Honoraria (self): Bayer; Honoraria (self): Daiichi Sankyo; Honoraria (self): Janssen Oncology; Honoraria (self): Kyowa Hakko Kirin; Honoraria (self), Research grant / Funding (institution): Lilly Japan; Honoraria (self): Nippon Kayaku; Honoraria (self), Research grant / Funding (institution): Ono Pharmaceutical; Honoraria (self): Zeria Pharmaceutical; Research grant / Funding (institution): GlaxoSmithKline; Research grant / Funding (institution): Immunogen; Research grant / Funding (institution): Kaken Pharmaceutical; Research grant / Funding (institution): Oncotherapeutics; Research grant / Funding (institution): Shionogi. I.B. Vergote: Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy: Eisai; Advisory / Consultancy, Travel / Accommodation / Expenses: PharmaMar; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Advaxis; Advisory / Consultancy: Merck Sharp & Dohme Corp.; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Genmab; Advisory / Consultancy: Millennium Pharmaceuticals; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: Immunogen; Advisory / Consultancy, Travel / Accommodation / Expenses: TESARO, Inc.; Advisory / Consultancy, Research grant / Funding (institution): Oncoinvent; Advisory / Consultancy: Roche; Advisory / Consultancy: Sotio; Travel / Accommodation / Expenses: Takeda; Research grant / Funding (institution): Amgen. J. Sehouli: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self): Eisai; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Clovis; Honoraria (self): Olympus; Honoraria (self): Johnson&Johnson; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: PharmaMar; Honoraria (self): Teva Pharmaceutical Industries Ltd.; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: TESARO, Inc.; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck Sharpe & Dohme Corp.; Advisory / Consultancy: Lilly; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche. P. Zola: Advisory / Consultancy, Travel / Accommodation / Expenses: TESARO, Inc.; Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Research grant / Funding (self): Roche. R.M. Wenham: Research grant / Funding (self), Shareholder / Stockholder / Stock options: Ovation Diagnostics; Advisory / Consultancy, Speaker Bureau / Expert testimony: TESARO, Inc.; Advisory / Consultancy: Merck; Advisory / Consultancy, Speaker Bureau / Expert testimony: Clovis; Advisory / Consultancy, Speaker Bureau / Expert testimony: Genentech; Advisory / Consultancy: Mersana Therapeutics; Research grant / Funding (self): TapImmune; Research grant / Funding (self): Merck; Research grant / Funding (self): Prescient Therapeutics. P. Pautier: Advisory / Consultancy: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: PharmaMar; Advisory / Consultancy: GlaxoSmithKline. S. Lheureux: Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): TESARO, Inc.; Research grant / Funding (institution): Roche/Genentech; Research grant / Funding (institution): Regeneron. K. Hasegawa: Honoraria (self), Research grant / Funding (self): Daiichi-Sankyo; Honoraria (self): Chugai; Honoraria (self), Advisory / Consultancy: Merck Sharpe & Dohme Corp.; Honoraria (self): AstraZeneca; Research grant / Funding (self): Yakult Honsha; Research grant / Funding (self): Pfizer. C-H. Lai: Research grant / Funding (self): Roche; Research grant / Funding (self): TTY Biopharm. A. Gonzalez-Martinez: Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca; Advisory / Consultancy: Clovis; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Merck Sharpe & Dohme Corp.; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): TESARO, Inc.; Advisory / Consultancy, Speaker Bureau / Expert testimony: Pharmama. Q. Liu: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck & Co., Inc. S.M. Keefe: Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck & Co., Inc. M. Puglisi: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck & Co., Inc. All other authors have declared no conflicts of interest.

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