NCT03517449 · OUTCOME

PFS Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on BICR in All-comer Participants

Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775]) · Source last updated 2026-03-19

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

Measure: MEDIAN
Unit: Months
Interval / dispersion: 95% Confidence Interval
Time frame: Up to approximately 27 months

What was measured

PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression, as determined by Blinded Independent Central Review (BICR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter \[mm\]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.

Analysis population: Analysis population consisted of ITT population which included all randomized participants.

Groups in this outcome

Lenvatinib 20 mg + Pembrolizumab 200 mg

Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study

Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel

Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.

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
Lenvatinib 20 mg + Pembrolizumab 200 mg	411
Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel	416

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lenvatinib 20 mg + Pembrolizumab 200 mg	7.2	5.7	5.7	7.6	Not reported
Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel	3.8	3.6	3.6	4.2	Not reported

Source statistical analyses

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

ci Lower Limit
0.47
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.66
estimate Comment
Regression, Cox method
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
< 0.0001
p Value Comment
One-sided p-value based on log-rank test stratified by ECOG performance status, geographic region, and prior history of pelvic radiation.
param Type
Hazard Ratio (HR)
param Value
0.56
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.47
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.66
estimate Comment
Regression, Cox method
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
< 0.0001
p Value Comment
One-sided p-value based on log-rank test stratified by ECOG performance status, geographic region, and prior history of pelvic radiation.
param Type
Hazard Ratio (HR)
param Value
0.56
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
5.7
spread
5.7
upper Limit
7.6
value
7.2
group Id
OG001
lower Limit
3.6
spread
3.6
upper Limit
4.2
value
3.8

denoms

counts
group Id
OG000
value
411
group Id
OG001
value
416
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
id
OG000
title
Lenvatinib 20 mg + Pembrolizumab 200 mg
description
Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
id
OG001
title
Treatment of Physician's Choice(TPC):Doxorubicin or Paclitaxel

param Type

MEDIAN

population Description

Analysis population consisted of ITT population which included all randomized participants.

reporting Status

POSTED

time Frame

Up to approximately 27 months

title

PFS Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on BICR in All-comer Participants

type

PRIMARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice