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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
Advanced
Combined Agent(s)
Lenvatinib
Control Arm
Treatment of physician's choice (doxorubicin or paclitaxel)
Treatment Setting
Patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiotherapy
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
2.8 months
PFS HR
0.60 (0.50-0.72)
OS Control
12.0 months
OS Gain
5.4 months
OS HR
0.68 (0.56-0.84)
QoL Comment
No difference in QoL between treatment groups

Final Score (after adjustments)

Preliminary non-curative score
4
Final non-curative Score
4
Comment
FDA regular approval July 2020

FDA approval is restricted to patients whose tumours are not MSI-H or dMMR and so data shown are for the pMMR study population.
Issue date
28.04.2022
Release date
28.04.2022

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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