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297 Leap-005: evaluating the safety and efficacy of lenvatinib and pembrolizumab in patients previously treated for ovarian cancer, a multi-cohort phase 2 study
  1. Antonio Gonzalez-Martin1,
  2. Hyun Cheol Chung2,
  3. Esma Saada-Bouzid3,
  4. Eduardo Yanez4,
  5. Hélène Senellart5,
  6. Philippe A Cassier6,
  7. Bristi Basu7,
  8. Razi Ghori8,
  9. Peter Kubiak9,
  10. Alan Smith9,
  11. Kevin Norwood8 and
  12. Zarnie Lwin10
  1. 1Clínica Universidad de Navarra
  2. 2Yonsei Cancer Center, Yonsei University College of Medicine
  3. 3Department of Medical Oncology, Centre de Lutte Contre Le Cancer Antoine Lacassagne
  4. 4Oncology-Hematology Unit, Department of Internal Medicine, School of Medicine, Universidad de la Frontera
  5. 5Institut de Cancérologie de L’ouest, Centre René Gauducheau Ico
  6. 6Department of Medical Oncology, Centre Léon Bérard
  7. 7Department of Oncology, University of Cambridge
  8. 8Merck and Co., Inc
  9. 9Eisai Ltd., Hatfield, UK
  10. 10Royal Brisbane and Women’s Hospital, University of Queensland


Introduction/Background Lenvatinib, an antiangiogenic multiple receptor tyrosine kinase inhibitor, plus pembrolizumab, a programmed death-1 immune checkpoint inhibitor, demonstrated promising clinical benefit in a previous phase Ib/II trial across several cancer types (, NCT02501096). We assessed clinical outcomes with lenvatinib plus pembrolizumab in patients with ovarian cancer in the ongoing, open-label, multicohort, phase II LEAP-005 study (, NCT03797326).

Methodology Female patients aged ≥18 years with histologically/cytologically confirmed metastatic/unresectable ovarian cancer, measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1), Eastern Cooperative Oncology Group (ECOG) performance status 0/1, and 3 prior lines of therapy were enrolled. Patients received lenvatinib 20 mg daily plus pembrolizumab 200 mg every 3 weeks for 35 cycles, or until confirmed disease progression or unacceptable toxicity. Primary endpoints were objective response rate (ORR; response assessed every 9 weeks for 54 weeks, then every 12 weeks, by blinded independent central review per RECIST v1.1) and safety. Secondary endpoints included disease control rate, duration of response, and progression-free survival.

Results 31 patients with ovarian cancer received ≥1 dose of lenvatinib plus pembrolizumab in LEAP-005 (median age 62 years [range 40–76]); median study follow-up was 7.8 months (range, 4.6–12.4) as of April 10, 2020. ORR was 32% (95% confidence interval, 17–51); other efficacy endpoints were also favorable (table 1). Treatment-related adverse events occurred in 29 (94%) patients (table 1).

Abstract 297 Table 1

Conclusion Lenvatinib plus pembrolizumab demonstrated encouraging efficacy and manageable safety in patients with heavily pretreated ovarian cancer, including those with prior platinum failure and those with previous bevacizumab exposure.

Disclosures Antonio González-Martín: Advisory/Consultancy: Amgen, AstraZeneca, Clovis Oncology, Genmab, GSK, ImmunoGen, Mersana, Merck Sharp & Dohme, Novartis, Oncoinvent, Pfizer/Merck, PharmaMar, Roche, Sotio; Speaker Bureau: AstraZeneca, PharmaMar, Roche, GSK; Research Grant/Funding: Roche, TESARO: A GSK Company; Travel/Accommodation/Expenses: AstraZeneca, PharmaMar, Roche, TESARO: A GSK Company

Hyun Cheol Chung: Grants/Research Support: Lilly, GSK, MSD, Merck-Serono, BMS/Ono, Taiho, Amgen, Beigene, Incyte; Honoraria: Merck-Serono, Lilly/Foundation Medicine; Consultation: Taiho, Celltrion, MSD, Lilly, Quintiles, BMS, Merck-Serono, Gloria, Beigene, Amgen, Zymework

Esma Saada-Bouzid: Advisory/Consultancy: BMS, MSD; Travel/Accommodation: AstraZeneca, BMS, MSD

Eduardo Yanez: Consultant/Advisory Board: BMS, Merck Serono; Research Grant: Amgen, Pfizer, Astellas, BMS, Roche, Abbvie, MSD

Hélène Senellart: Nothing to disclose.

Philippe A. Cassier: Honoraria: Novartis, Roche/Genentech, Blueprint Medicines, Amgen, AstraZeneca; Research Funding: Novartis, Roche/Genentech, Lilly, Blueprint Medicines, Bayer, AstraZeneca, Celgene, Plexxikon, Abbvie, BMS, Merck Serono, MSD, Taiho Pharmaceutical, Toray Industries, Transgene, Loxo, GSK, Innate Pharma, Janssen (all paid to institution); Travel, Accomodations, Expenses: Roche, Amgen, Novartis, BMS, MSD, Netris Pharma.

Bristi Basu: Consultancy: GenMab (paid to institution); Advisory Board: Roche, Eisai Europe Limited, research grant from Celgene Ltd (all paid to institution); Speakers Bureau: Eisai Europe Ltd (paid to institution); Travel and Registration for Congress: Bayer.

Razi Ghori: employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA

Peter Kubiak: employee of Eisai Inc., Woodcliff Lake, NJ, USA

Alan Smith: employee of Eisai Ltd., Hatfield, UK

Kevin Norwood: employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA

Zarnie Lwin: Received honoraria for consulting, advisory role or travel sponsorship from AbbVie; AstraZeneca; BMS; Roche; and Merck

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