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 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
- 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
- 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