394TiP - KEYNOTE-122: Phase 2 study of pembrolizumab versus standard-of-care chemotherapy in platinum-pretreated, recurrent or metastatic nasopharyngeal car...

Date 17 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Anticancer agents
Immunotherapy
Head and Neck Cancers
Presenter Anthony T.C. Chan
Citation Annals of Oncology (2016) 27 (suppl_9): ix112-ix122. 10.1093/annonc/mdw587
Authors A.T.C. Chan1, V. Lee2, R. Ngan3, K.F. To1, M. Ahn4, Q.S. Ng5, R. Hong6, J. Lin7, R.F. Swaby8, C. Gause8, S. Saraf8, A. Spreafico9
  • 1Sir Yk Pao Centre For Cancer, The Chinese University of Hong Kong, New Territory - Hong Kong/CN
  • 2Li Ka Shing Faculty Of Medicine, The University of Hong Kong, Hong Kong - Hong Kong/CN
  • 3Department Of Clinical Oncology, Queen Elizabeth Hospital, Hong Kong/CN
  • 4Samsung Medical Center, Sungkyunkwan University, 135-710 - Seoul/KR
  • 5Division Of Medical Oncology, National Cancer Centre Singapore, 169610 - Singapore/SG
  • 6Department Of Oncology, National Taiwan University Hospital, 100 - Taipei/TW
  • 7Department Of Radiation Oncology, Taichung Veterans General Hospital, 40705 - Taichung/TW
  • 8Department Of Clinical Oncology, Merck & Co., Inc., 07033 - Kenilworth/US
  • 9Division Of Medical Oncology And Hematology, Princess Margaret Cancer Centre, M5G 2M9 - Toronto/CA

Abstract

Background

Current treatment for recurrent/metastatic nasopharyngeal carcinoma (NPC) that progresses on a platinum-based regimen is limited. Prolonged exposure to Epstein-Barr virus (EBV) in NPC leads to increased expression of programmed death 1 (PD-1), resulting in suppressed T-cell immunity and tumor surveillance. Pembrolizumab is a monoclonal anti–PD-1 antibody designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. In the phase 1b KEYNOTE-028 study, pembrolizumab was associated with an overall response rate of 22% (6/27) in mostly heavily pretreated patients with NPC. KEYNOTE-122 (NCT02611960) is a multicenter, open-label, randomized phase 2 study designed to evaluate the efficacy and safety of pembrolizumab monotherapy versus chemotherapy in patients with platinum-pretreated, recurrent or metastatic NPC.

Trial design

Key eligibility criteria include age ≥18 years, histologically confirmed nonkeratinizing differentiated NPC (WHO Class II) or undifferentiated NPC (WHO Class III), metastatic or recurrent disease, EBV positivity determined locally or centrally by EBV-encoded small RNA in situ hybridization, previous treatment with platinum-containing regimen, ECOG performance status 0-1, and measurable disease per RECIST v1.1. Patients will be randomly assigned 1:1 to receive either pembrolizumab 200 mg every 3 weeks (Q3W) or investigator’s choice of chemotherapy (capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle, gemcitabine 1250 mg/m2 once per week on days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m2 Q3W). Treatment will continue until disease progression, unacceptable toxicity, investigator decision, or 35 cycles of pembrolizumab. Response will be evaluated every 6 weeks for the first year of treatment and every 9 weeks thereafter per RECIST v1.1 by central imaging assessment. Primary end points are overall survival and progression-free survival per RECIST v1.1 by central imaging assessment; secondary end points include objective response rate and duration of response. Enrollment is ongoing and will continue until approximately 160 patients have enrolled.

Clinical trial indentification

NCT02611960

Legal entity responsible for the study

Merck & Co., Inc.

Funding

Merck & Co., Inc.

Disclosure

A.T.C. Chan: Research funding from Merck. V. Lee: Received honoraria as speaker/teach from Eli Lilly Asia Inc., and sponsorship of airline tickets and hotel accommodation as speaker at international oncology conferences from Merck Sharp and Dohme. R.F. Swaby: Employee of Merck and own stock in Merck. C. Gause: Merck employee and own Merck stock. S. Saraf: Employee of Merck. All other authors have declared no conflicts of interest.