NCT05722015 · OUTCOME

Cycle 3: Trough Serum Concentration (Ctrough) of Pembrolizumab at Steady State

A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77) · Source last updated 2026-08-26

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

Measure: GEOMETRIC_MEAN
Unit: μg/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Cycle 3: Arm 1: Day 1: Predose and Days 4, 10, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4 and 42 postdose (cycle length = 42 days)

What was measured

Ctrough was defined as the lowest serum concentration of pembrolizumab reached at steady state. Blood samples were collected at pre-specified timepoints for the determination of Ctrough. Per protocol, geometric mean Ctrough value of pembrolizumab at steady state of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and of pembrolizumab in arm 2 was presented.

Analysis population: All randomized participants who received a dose in Cycle 1 and Cycle 3 with at least 1 valid postdose PK sample available in Cycle 1 through Cycle 3 and for whom a model-based assessment of Ctrough could be made.

Groups in this outcome

Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy

Participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.

Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy

Participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion in combination with platinum doublet chemotherapy.

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
Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy	202
Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy	101

Reported measurements

Source class 1

Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy	39.23	43.29	Not reported	Not reported	Not reported
Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy	23.49	44.23	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
1.52
ci Num Sides
TWO_SIDED
ci Pct Value
94
ci Upper Limit
1.84
estimate Comment
GMR was calculated as the ratio of GM of Cycle 3 Ctrough in Arm 1 to that of Arm 2. The associated 94% CI were calculated using Welch's t test.
group Ids
OG000
OG001
non Inferiority Comment
Non-inferiority margin is 0.8.
non Inferiority Type
NON_INFERIORITY
p Value
<0.00001
param Type
GMR
param Value
1.67
statistical Comment
One sided p-value was calculated using Welch's t test.
statistical Method
Welch's t test

Complete source fields

analyses

ci Lower Limit
1.52
ci Num Sides
TWO_SIDED
ci Pct Value
94
ci Upper Limit
1.84
estimate Comment
GMR was calculated as the ratio of GM of Cycle 3 Ctrough in Arm 1 to that of Arm 2. The associated 94% CI were calculated using Welch's t test.
group Ids
OG000
OG001
non Inferiority Comment
Non-inferiority margin is 0.8.
non Inferiority Type
NON_INFERIORITY
p Value
<0.00001
param Type
GMR
param Value
1.67
statistical Comment
One sided p-value was calculated using Welch's t test.
statistical Method
Welch's t test

classes

categories
measurements
group Id
OG000
spread
43.29
value
39.23
group Id
OG001
spread
44.23
value
23.49

denoms

counts
group Id
OG000
value
202
group Id
OG001
value
101
units
Participants

description

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.
id
OG000
title
Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy
description
Participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion in combination with platinum doublet chemotherapy.
id
OG001
title
Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy

param Type

GEOMETRIC_MEAN

population Description

All randomized participants who received a dose in Cycle 1 and Cycle 3 with at least 1 valid postdose PK sample available in Cycle 1 through Cycle 3 and for whom a model-based assessment of Ctrough could be made.

reporting Status

POSTED

time Frame

Cycle 3: Arm 1: Day 1: Predose and Days 4, 10, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4 and 42 postdose (cycle length = 42 days)

title

Cycle 3: Trough Serum Concentration (Ctrough) of Pembrolizumab at Steady State

type

PRIMARY

unit Of Measure

μg/mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice