A
5
Indication details
- Control Arm
- Docetaxel
- Therapeutic Indication
- Locally advanced or metastatic NSCLC with PD-L1 expression ≥1% TPS after ≥1 prior ChT regimen. Patients with EGFR or ALK-positive tumour mutations should also have received targeted therapy (2 mg/kg and 10mg/kg pooled data)
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Locally advanced or metastatic
- Tumour Sub-Group
- PD-L1 ≥50%
- Trial Name
- KEYNOTE-010
- NCT Number
- NCT01905657
- Trial Phase
- Phase II/III
Approval details
- FDA Approval
- FDA approved
- EMA Approval
- EMA (June 2016) EC decision August 2016
- Comment
- EMA and FDA approvals based on PD-L1 ≥1% TPS
Primary Outcome(s)
- Primary Outcome(s)
- OS - >50% 2 and 10 mg/kg
- Evaluated Outcome
- OS
- Form(s)
- Form 2a / Form 1
Outcome Data
- OS Control
- 8.2 months
- OS Gain
- 8.7 months, 5-year OS gain 16.8 %
- OS HR
- 0.55 (0.44--0.69)
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
- Toxicity Comment
-
Reduced grade 3-5 AEs: 16.1% versus 36.6%
Score (after adjustments)
- Preliminary non-curative score
-
4
- Toxicity adjustment
- 1+
- Non-curative score
-
5
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 53
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 18.04.2025
Legend
Information about symbols, abbrevations and color codes
Red = negative
Green = positive
Grey = neutral
?
Grey + ? = neutral with pending data
- DFS
- Disease-Free Survival
- DoR
- Duration of Response
- EFS
- Event-Free Survival
- HR
- Hazard Ratio
- NEB
- No evaluable benefit
- NI
- Non-inferiority Study
- ORR
- Overall Response Rate
- OS
- Overall Surival
- pCR
- Pathological Complete Response/Remission
- PFS
- Progression-Free Survival
- QoL
- Quality of Life
- RFS
- Relapse-Free Survival
- RR
- Response Rate
QoL adjustments
Other adjustments*
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
QoL adjustments
Red = negative / deterioration
Green = positive / improvement
Other adjustments*
Red = negative / deterioration
Green = positive / improvement
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include:
- Long-term plateau in the survival curve
- Long-term plateau in the PFS curve
- Early stopping or crossover
- Only improved PFS mature data shows no OS advantage and no improved Qol.