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