xRead - An Update on Immunotherapy in Head and Neck Cancer (November 2025)

n engl j med 393;1 nejm.org July 3, 2025 44 End Point P value

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Table 2. Pathological Response According to Blinded Independent Pathological Review.* Downloaded from nejm.org at Albany Medical College on July 20, 2025. For personal use only. No other uses without permission. Copyright © 2025 Massachusetts Medical Society. All rights reserved.

CPS-10 Population (N = 465)

CPS-1 Population (N = 682)

Total Population (N = 714)

Pembrolizumab (N = 234)

Control (N = 231)

Pembrolizumab (N = 347)

Control (N = 335)

Pembrolizumab (N = 363)

Control (N = 351)

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Key secondary end point: major patho logical response† No. with response

32

0

34

0

34

0

Incidence — % (95% CI)

13.7 (9.5–18.8)

0.0 (0.0–1.6)

9.8 (6.9–13.4)

0.0 (0.0–1.1)

9.4 (6.6–12.8)

0.0 (0.0–1.0)

Estimated difference (95% CI) — percentage points‡

13.7 (9.7–18.7)

9.8 (7.0–13.3)

9.3 (6.7–12.8)

<0.001

<0.001

<0.001

Additional secondary end point: patho logical complete response§ No. with response

10

0

11

0

11

0

Incidence — % (95% CI)

4.3 (2.1–7.7)

0.0 (0.0–1.6)

3.2 (1.6–5.6)

0.0 (0.0–1.1)

3.0 (1.5–5.4)

0.0 (0.0–1.0)

Estimated difference (95% CI) — percentage points

4.2 (2.1–7.6)

3.1 (1.6–5.6)

3.0 (1.5–5.3)

* Participants in the pembrolizumab group were assigned to receive neoadjuvant and adjuvant pembrolizumab in addition to standard care; adjuvant pembrolizumab was planned to start concomitantly with postoperative radiotherapy or chemoradiotherapy. Participants in the control group were assigned to receive standard care. † A major pathological response was defined as having no more than 10% residual viable invasive squamous-cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. ‡ The estimated difference and 95% confidence interval were calculated by means of the Miettinen and Nurminen method, with stratification according to primary tumor site (oropharynx or oral cavity vs. larynx vs. hypopharynx) and tumor stage (III vs. IVA). § A pathological complete response was defined as having no residual invasive squamous-cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. Incidence was estimated by means of the Clopper–Pearson method; the between-group difference was estimated by means of the Miettinen and Nurminen stratified method.