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4
ESMO-MCBS v1.1
Scorecard version: 1

Indication details

Tumour Type
Thoracic Malignancies
Tumour Sub-type
Non-small-cell Lung Cancer
Tumour stage
Advanced
Combined Agent(s)
Chemotherapy (Pemetrexed)
Control Arm
Chemotherapy
Treatment Setting
Previously untreated without EGFR or ALK mutations
Trial Name
KEYNOTE-189

Primary Outcome(s)

Primary Outcome(s)
PFS and OS (Crossover allowed)
Form(s)
Form 2a

Outcome Data

PFS Control
4.9 months
PFS Gain
3.9 months
PFS HR
0.52 (0.43-0.64)
OS Control
11.3 months
OS Gain
Above the cut-off of 3 months
OS HR
0.49 (0.38-0.64)
QoL Comment
Delayed deterioration (exploratory outcome not eligible for upgrade)
Toxicity Comment
Similar toxicity

Final Score (after adjustments)

Preliminary non-curative score
4
Final non-curative Score
4
Release date
17.05.2019
Last update
30.04.2020

DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; HR, hazard ratio; iDFS, invasive disease-free survival; ITT, intention to treat; ORR, overall response rate; OS, overall survival; pCR, pathologic complete response/remission; PFS, progression-free survival; PE, point estimate; 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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