48TiP - KEYNOTE-122: Phase 2 study of pembrolizumab versus standard-of-care chemotherapy in platinum-pretreated, recurrent or metastatic nasopharyngeal car...

Date 05 November 2016
Event ESMO Symposium on Immuno-Oncology 2016
Session Lunch and general poster viewing
Presenter Quan Sing Ng
Citation Annals of Oncology (2016) 27 (suppl_8): viii4-viii17. 10.1093/annonc/mdw527
Authors Q.S. Ng1, A. Spreafico2, V. Lee3, R.K.C. Ngan4, K.F. To5, M. Ahn6, R. Hong7, J. Lin8, R.F. Swaby9, A.T.C. Chan4
  • 1Department Of urologic Oncology, National Cancer Centre Singapore, 169610 - Singapore/SG
  • 2Division Of Medical Oncology And Hematology, Princess Margaret Cancer Centre, Toronto/CA
  • 3Department Of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong/CN
  • 4Department Of Clinical Oncology, Queen Elizabeth Hospital, Hong Kong/CN
  • 5Department Of Anatomical And Cellular Pathology, Sir YK Pao Centre for Cancer, The Chinese University of Hong Kong, Hong Kong/CN
  • 6Department Of Hematology & Oncology, Samsung Medical Center, Sungkyunkwan University, Seoul/KR
  • 7Department Of Oncology, National Taiwan University Hospital, Taipei/TW
  • 8Department Of Radiation Oncology, Taichung Veterans General Hospital, 40705 - Taichung/TW
  • 9Department Of Clinical Oncology, Merck & Co., Inc., Kenilworth/US

Abstract

Aim/Background

Treatment for recurrent/metastatic nasopharyngeal carcinoma (NPC) that progresses on a platinum-based regimen includes gemcitabine, capecitabine, or docetaxel. Prolonged exposure to Epstein-Barr virus (EBV) in NPC leads to increased expression of 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 PD-L1 and PD-L2. In the phase 1b KEYNOTE-028 study, pembrolizumab had an ORR of 22% (6/27) in heavily pretreated (≥3 lines) 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 per RECIST v1.1 by central imaging assessment. Enrollment is ongoing and will continue until approximately 160 patients have enrolled.

Clinical trial identification

ClinicalTrials.gov, NCT02611960

Legal entity responsible for the study

Merck & Co., Inc.

Funding

Merck & Co., Inc.

Disclosure

V. Lee: Received honoraria from Eli Lilly Asia Inc., and travel accommodations for international conference from Merck Sharp and Dohme. M-J. Ahn: Is on the advisory committee for AstraZeneca, ONO, Boehringer Ingelheim, Novartis, Lilly, BMS, and Merck. R.F. Swaby: I am a Merck employee and I own Merck stock. A.T.C. Chan: Research funding from Merck. All other authors have declared no conflicts of interest.