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3
ESMO-MCBS v1.1
Scorecard version: 1

Indication details

Tumour Type
Thoracic Malignancies
Tumour Sub-type
Non-small-cell Lung Cancer
Tumour stage
Metastatic
Combined Agent(s)
Carboplatin plus nab-paclitaxel
Control Arm
Carboplatin plus nab-paclitaxel
Treatment Setting
In combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous NSCLC who do not have EGFR mutant or ALK positive NSCLC
Trial Name
IMpower130

Primary Outcome(s)

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

Outcome Data

PFS Control
5.5 months
PFS Gain
1.5 months
PFS HR
0.64 (0.54-0.77)
OS Control
13.9 months
OS Gain
4.7 months
OS HR
0.79 (0.64-0.98)

Final Score (after adjustments)

Preliminary non-curative score
3
Final non-curative Score
3
Comment
EMA (CHMP) July 2019 EC decision September 2019
Issue date
16.03.2020
Release date
16.03.2020

DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; HR, hazard ratio; iDFS, invasive disease-free survival; ITT, intention to treat; mPFS, median progression-free survival; ORR, overall response rate; OS, overall survival; pCR, pathologic complete response/remission; PFS, progression-free survival; QoL, quality of life; RFS, relapse-free survival; RR, response rate

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