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4
ESMO-MCBS v1.1
Scorecard version: 1

Indication details

Tumour Type
Gynaecological Malignancies
Tumour Sub-type
Endometrial Cancer
Tumour stage
Recurrent or advanced
Combined Agent(s)
Lenvatinib
Control Arm
Treatment of physician's choice (doxorubicin or paclitaxel)
Treatment Setting
Patients with advanced or recurrent endometrial carcinoma who have progressed following prior platinum-containing therapy in any setting and who are not candidates for curative surgery or RT
Trial Name
KEYNOTE-775

Primary Outcome(s)

Primary Outcome(s)
OS
Evaluated Outcome
OS
Form(s)
Form 2a

Outcome Data

PFS Control
3.8 months
PFS Gain
3.4 months
PFS HR
0.56 (0.47-0.66)
OS Control
11.4 months
OS Gain
6.9 months
OS HR
0.62 (0.51-0.75)
QoL Comment
No difference in QoL between treatment groups

Final Score (after adjustments)

Preliminary non-curative score
4
Final non-curative Score
4
Comment
EMA (CHMP) October 2021 EC decision December 2021

EMA approval is irrespective of MSI/MMR status and so data shown are for the entire study population.
Issue date
28.04.2022
Release date
28.04.2022
Last update
20.03.2023

ChT; chemotherapy; DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; FFS, failure-free survival; HR, hazard ratio; HRD, homologus recombination deficiency; HRP, homologous recombination proficient; iDFS, invasive disease-free survival; ITT, intention to treat; MFS, metastasis-free survival; NS, not significant; ORR, overall response rate; OS, overall survival; pCR, pathologic complete response/remission; PE, point estimate; PFS, progression-free survival; QoL, quality of life; RFS, relapse-free survival; RR, response rate; rPFS, radiographic progression-free survival; SD, stable disease; SSA, somatostatin analogue; SSTR, somatostatin receptor; TKI, tyrosine kinase inhibitor, TTP, time to progression; WT, wild type

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