NCT04590963 · OUTCOME

Percentage of Participants With Objective Response (OR) Per RECIST 1.1 in HPV-unrelated Analysis Set

Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer · Source last updated 2026-09-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: Percentage of Participants
Interval / dispersion: Not reported
Time frame: Baseline (-28 to -1) through 17.5 months (maximum observed duration)

What was measured

The OR is defined as the percentage of participants with at least one confirmed investigator-assessed response of complete response (CR) or partial response (PR) as assessed by RECIST 1.1 guidelines. The CR is defined as disappearance of all TLs and NTLs, any pathological lymph nodes (target and non-target) must have reduction in short axis \< 10 mm, and no new lesions. The PR is defined as at least a 30% decrease in the sum of the diameters (SoD) of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. Percentage of participants with OR is reported. Participants who had measurable disease at baseline per the site investigator were analyzed for this outcome.

Analysis population: The HPV-unrelated analysis set included all participants who were randomized at least 2 months before the 11May2022 DCO (i.e. on or before 11Mar2022) and were either OPC HPV negative or non OPC regardless of the HPV status. Participants who had measurable disease at baseline per the site investigator were analyzed for this outcome.

Groups in this outcome

Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2

Participants received IV monalizumab 750 mg Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

Placebo Q2W + Cetuximab 400 mg/m^2

Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2	145
Placebo Q2W + Cetuximab 400 mg/m^2	71

Reported measurements

Source class 1

Values in Percentage of Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2	15.2	Not reported	0.274	1.154	Not reported
Placebo Q2W + Cetuximab 400 mg/m^2	23.9	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.274
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.154
estimate Comment
The analysis was performed using a logistic regression model, with treatment as a covariate and adjusting for WHO/ECOG PS, and number of lines of prior therapy in the R/M setting with 95% CI calculated by profile likelihood.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.115
param Type
Odds Ratio (OR)
param Value
0.56
statistical Comment
P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.
statistical Method
Regression, Logistic

Complete source fields

analyses

ci Lower Limit
0.274
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.154
estimate Comment
The analysis was performed using a logistic regression model, with treatment as a covariate and adjusting for WHO/ECOG PS, and number of lines of prior therapy in the R/M setting with 95% CI calculated by profile likelihood.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.115
param Type
Odds Ratio (OR)
param Value
0.56
statistical Comment
P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.
statistical Method
Regression, Logistic

classes

categories
measurements
group Id
OG000
lower Limit
0.274
upper Limit
1.154
value
15.2
group Id
OG001
value
23.9

denoms

counts
group Id
OG000
value
145
group Id
OG001
value
71
units
Participants

description

groups

description
Participants received IV monalizumab 750 mg Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
id
OG000
title
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
description
Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
id
OG001
title
Placebo Q2W + Cetuximab 400 mg/m^2

param Type

NUMBER

population Description

The HPV-unrelated analysis set included all participants who were randomized at least 2 months before the 11May2022 DCO (i.e. on or before 11Mar2022) and were either OPC HPV negative or non OPC regardless of the HPV status. Participants who had measurable disease at baseline per the site investigator were analyzed for this outcome.

reporting Status

POSTED

time Frame

Baseline (-28 to -1) through 17.5 months (maximum observed duration)

title

Percentage of Participants With Objective Response (OR) Per RECIST 1.1 in HPV-unrelated Analysis Set

type

SECONDARY

unit Of Measure

Percentage of Participants

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Preserved source evidence · Not medical advice