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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)