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5
ESMO-MCBS v1.1
Scorecard version: 1

Indication details

Tumour Type
Thoracic Malignancies
Tumour Sub-type
Non-small-cell Lung Cancer
Tumour Sub-Group
PD-L1 ≥1%
Tumour stage
Metastatic
Control Arm
Docetaxel
Treatment Setting
2nd line after platinum-based therapy OR TKI (for EGFR/ALK Mutated) advanced NSCLC>1% tumour cell PD-L1 expression (all) Pembro 2mg/kg
Trial Name
KEYNOTE-010

Primary Outcome(s)

Primary Outcome(s)
OS - All >1% - 2mg/kg
Evaluated Outcome
OS
Form(s)
Form 2a

Outcome Data

OS Control
8.5 months
OS Gain
1.9 months
OS HR
0.71 (0.58-0.88)
Toxicity Comment
Reduce grade 3/4 adverse events 13/16% vs 35%

Final Score (after adjustments)

Preliminary non-curative score
4
Toxicity adjustment
1+
Final non-curative Score
5
Long-term plateau in the survival curve
2-year survival gain >10%
Comment
EMA (June 2016) EC decision August 2016
Issue date
11.12.2018
Release date
11.12.2018
Last update
22.12.2020

ChT; chemotherapy; DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; FFS, failure-free survival; HR, hazard ratio; iDFS, invasive disease-free survival; ITT, intention to treat; MFS, metastasis-free survival; 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; SD, stable disease; SSA, somatostatin analogue; SSTR, somatostatin receptor; TKI, tyrosine kinase inhibitor, TTP, time to progression

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