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Table 1 Summary of trial- and patient-level characteristics and clinical endpoints of included trials

From: Comparative safety and efficacy of anti-PD-1 monotherapy, chemotherapy alone, and their combination therapy in advanced nasopharyngeal carcinoma: findings from recent advances in landmark trials

Items KEYNOTE-028 NCI-9742 CheckMate-358 JS001 SHR-1210 (monotherapy) GEM20110714a SHR-1210 (combination)
Trial-level characteristics
 Region Taiwan International-collaborated International-collaborated Mainland China Mainland China Mainland China Mainland China
 Inclusion period 2014–2016 2015–2016 2015–2017 2016–2018 2016–2017 2012–2015 2017–2017
 Phase 1 2 1/2 2 1 3 1
 Key eligibility criteria Recurrent/metastatic NPC; Failure on prior standard therapy; PD-L1 expression ≥1% Recurrent/metastatic NPC; Failure on at least one prior line of platinum-based chemotherapy Recurrent/metastatic NPC; ≤ 2 prior systemic therapies Recurrent/metastatic NPC; Failure on at least one prior line of platinum-based chemotherapy Recurrent/metastatic NPC; Failure on at least one prior line of platinum-based chemotherapy Treatment-naive recurrent/metastatic NPC Treatment-naive recurrent/metastatic NPC
 Experimental regimen Anti-PD-1: Pembrolizumab 10 mg/kg q2wks up to 2 years or until disease progression or unacceptable toxicity Anti-PD-1: Nivolumab 3 mg/kg q2wks on a 4-week cycle until disease progression Anti-PD-1: Nivolumab 240 mg/kg q2wks until disease progression Anti-PD-1: JS001 3 mg/kg q2wks until disease progression or unacceptable toxicity Anti-PD-1: Camrelizumab at escalating doses of 1, 3 and 10 mg/kg, and a bridging dose of 200 mg per dose q2wks until unacceptable toxicity Chemotherapy: Gemcitabine 1 g/m2 (days 1 and 8), and cisplatin 80 mg/m2 (day 1) q3wks for six cycles Anti-PD-1 + chemotherapy: Camrelizumab 200 mg (day 1), gemcitabine 1 g/m2 (days 1 and 8), cisplatin 80 mg/m2 (day 1) q3wks for six cycles followed by camrelizumab 200 mg maintenance q3wks
 Sample size 27 45 24 143 93 181 23
Patient-level characteristics
 Age, median (range), years 52 (18–68) 57 (37–76) 51 (NR) 46 (24–71) 45 (38–52) 47 (39–55) 44 (34–51)
 Sex, male, n (%) 21/27 (77.8) 35/45 (77.8) 21/24 (88%) 121/143 (84.6) 75/93 (81) 148/181 (83.1) 17/23 (74)
PD-L1 expressionb
  < 1%, n (%) 0 24/42 (57.1) 76/136 (55.9)
  ≥ 1%, n (%) 27/27 (100) 18/42 (42.9) 60/136 (44.1)
Clinical endpoints
 Median follow-up, months 20.0 12.5 26.0 NR 9.9 22.0 10.2
 ORR (%) 26.3 20.5 20.8 23.2 34.1 64.1 90.9
OS
 Median (months) 16.5 17.1 NR NR NR 29.1 NR
 1-year rate (%) 63.0 59.0 NR NR NR 83.2 NR
PFS
 Median (months) 6.5 2.8 2.4 NR 9.9 7.0 10.2
 1-year rate (%) 33.4 19.3 NR NR 27.1 19.6 61.4
 All grade AEs (%) 74.1 NR 54.2 92.3 96.8 91.7 100
 Grade 3–5 AEs (%) 29.6 22.2 8.3 24.5 16.1 42.8 87.0
  1. Abbreviations: AEs adverse events, EBV Epstein-Barr virus, GP Gemcitabine and Cisplatin, NPC nasopharyngeal carcinoma, NR not reported, ORR objective response rate, OS overall survival, q2/3wks every 2/3 weeks, PFS progression-free survival, PD-1 programmed death-1, PD-L1 programmed death-ligand 1
  2. a Only paients from the GP arm was included, as it proved that GP regimen significantly prolonged PFS in patients with recurrent or metastatic NPC compared to standard fluorouracil plus cisplatin regimen, and currently GP is used as the first-line therapy for recurrent/metastatic diseases
  3. b Methods of PD-L1 expression evaluation, KEYNOTE-407 trial: The PD-L1 expression was assessed baseline on an archived formalin-fixed, paraffin-embedded tumor sample or a newly obtained biopsy sample using a laboratory-developed prototype immunohistochemical assay (QualTek Molecular Laboratories, Goleta, CA). PD-L1 positivity was defined as membranous staining on 1% or more of a modified proportion score or interface pattern. NCI-9742 trial: The PD-L1 expression was assessed based on paraffin-embedded NPC tumors using the immunohistochemical analysis of PD-L1 (anti-human PD-L1 antibody, clone 22C3, PD-L1 IHC 22C3; pharmDx assay; Agilent Technologies, Santa Clara, CA). PD-L1 expression in tumor cells and immune cells was scored as the percentage of tumor cells and immune cells with membranous straining, respectively. JS001 trial: The PD-L1 expression was assessed based on paraffin-embedded NPC tumors using the immunohistochemical analysis of PD-L1 (anti-human PD-L1 antibody, clone SP142; Spring BioScience, Pleasanton, CA)