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Pembrolizumab versus brentuximab vedotin in relapsed or refractory classical Hodgkin lymphoma (cHL): randomized phase 3 KEYNOTE-204 study

Date

08 Oct 2016

Session

Poster Display

Presenters

Michelle Fanale

Citation

Annals of Oncology (2016) 27 (6): 313-327. 10.1093/annonc/mdw375

Authors

M.A. Fanale1, J. Kline2, R. Chen3, V. Ribrag4, G. Salles5, I. Matsumura6, Y. Zhu7, A.D. Ricart7, A. Balakumaran7, P.L. Zinzani8

Author affiliations

  • 1 Department Of Medicine, The University of Texas MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 2 Hematology/oncology, University of Chicago, Chicago/US
  • 3 Hematology/oncology, City of Hope National Medical Center, Duarte/US
  • 4 Oncology, Institut Gustave Roussy, Villejuif/FR
  • 5 Hématologie, Centre Hospitalier Lyon Sud, Pierre Bénite/FR
  • 6 Department Of Internal Medicine, Kinki University, Osaka/JP
  • 7 Medical Oncology, Merck & Co, Inc., Kenilworth/US
  • 8 Medicine, University of Bologna, Bologna/IT
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Resources

Abstract 2979

Background

Patients with cHL who relapse after autologous stem-cell transplantation (auto-SCT) or are ineligible to proceed to transplantation have poor prognosis. The PD-1 ligands, PD-L1 and PD-L2, are frequently overexpressed in relapsed or refractory (R/R) cHL, and this is typically associated with chromosome 9p24.1 amplification. In the phase 1b KEYNOTE-013 study, PD-1 blockade with pembrolizumab (pembro) demonstrated an objective response rate (ORR) of 65% in heavily pretreated patients with cHL. KEYNOTE-204 (NCT02684292) is a randomized, international, open-label phase 3 study designed to compare the efficacy and safety of pembro vs brentuximab vedotin (BV) in patients with R/R cHL.

Trial design

This study will enroll patients age ≥18 years with R/R cHL who (1) have failed to achieve a response or progressed after auto-SCT and have not received prior BV; or (2) are not auto-SCT candidates because of chemo-resistant disease (unable to achieve complete or partial remission to salvage chemotherapy), advanced age, or comorbidities, and have received ≥2 prior multi-agent chemotherapy regimens that did not include BV. ∼300 patients will be randomized 1:1 to receive either pembro 200 mg Q3W or BV 1.8 mg/kg Q3W for up to 35 cycles or until documented disease progression, unacceptable toxicity, or investigator decision. Response will be assessed every 12 weeks by PET/CT scans per Revised Response Criteria for Malignant Lymphoma from the International Working Group (IWG) by central imaging vendor review. Primary end points are PFS and OS; secondary end points are ORR and complete remission rate. The primary assessment of efficacy end points will be based on blinded independent central review according to the IWG criteria; secondary/exploratory analyses of efficacy end points will be conducted using investigator assessment. Exploratory end points include PK profile, duration of response, and comparison of ORR in patients with PD-L1–positive versus PD-L1–negative lymphoid tumors. Enrollment to KEYNOTE-204 is ongoing.

Clinical trial identification

NCT02684292

Legal entity responsible for the study

Merck & Co., Inc.

Funding

Merck & Co., Inc.

Disclosure

Y. Zhu, A.D. Ricart, A. Balakumaran: Employee and stock ownership at Merck & Co, Inc. All other authors have declared no conflicts of interest.

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