Table 3 Tumour response to pembrolizumab as per RECIST v1.1 by central imaging vendor review (all-patients-as-treated population; N = 192)

From: Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: pooled analyses after long-term follow-up in KEYNOTE-012

 

All

N = 192

HPV associated

n = 45

Non-HPV associated

n = 147

 

No.

% (95% CI)

No.

% (95% CI)

No.

% (95% CI)

Overall response rate

34

18 (13–24)

11

24 (13–40)

23

16 (10–23)

Complete response

8

4 (2–8)

4

9 (3–21)

4

3 (1–7)

Partial response

26

14 (9–19)

7

16 (7–30)

19

13 (8–19)

Stable disease

33

17 (12–23)

7

16 (7–30)

26

18 (12–25)

Progressive disease

93

48 (41–56)

19

42 (28–58)

74

50 (42–59)

Non-CR/Non-PD

7

4 (2–7)

1

2 (0.1–12)

6

4 (2–9)

No assessment

21

11 (7–16)

6

13 (5–27)

15

10 (6–16)

Not evaluable

4

2 (0.6–5)

1

2 (0.1–12)

3

2 (0.4–6)

  1. Only confirmed responses are included.
  2. CR complete response, PD progressive disease, RECIST Response Evaluation Criteria in Solid Tumours.
  3. No assessment: patient discontinued before the first imaging assessment (reasons: progressive disease [n = 12]; adverse event [n = 3]; withdrawal by patient [n = 3]; death [n = 2]; protocol violation [n = 1]).
  4. Not evaluable: patient had post baseline imaging, but images were not of sufficient quality to determine response
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