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 ≥50%
- Tumour stage
- Metastatic
- Control Arm
- Docetaxel
- Treatment Setting
- 2nd line after platinum-based therapy OR TKI (for EGFR/ALK Mutated) advanced NSCLC>50% tumour cell PD-L1 expression Pembro 10mg/kg
- Trial Name
- KEYNOTE-010
Primary Outcome(s)
- Primary Outcome(s)
- OS - >50% 10 mg/kg
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 8.2 months
- OS Gain
- 9.1 months
- OS HR
- 0.50 (0.36-0.70)
- Toxicity Comment
- Reduce grade 3/4 adverse events 13/16% vs 37%
Final Score (after adjustments)
- Preliminary non-curative score
- 4
- Toxicity adjustment
- 1+
- Final non-curative Score
- 5
- 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