A
Indication details
- Control Arm
- Best supportive care
- FDA Therapeutic Indication
- Adjuvant treatment following resection and platinum-based ChT for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥1% of tumor cells
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Adjuvant
- Tumour Sub-Group
- PD-L1 ≥1%
- Trial Name
- IMpower010
- NCT Number
- NCT02486718
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval October 2021
- EMA Approval
- EMA (CHMP) April 2022 EC decision August 2022
- Comment
- EMA approval is limited to patients whose tumours express PD-L1 on ≥50% of tumour cells and who do not have EGFR-mutant or ALK-positive NSCLC. This approval was based on an analysis that does not meet the ESMO-MCBS requirements for subgroups (i.e. post hoc analysis) and so cannot be scored. Data shown are therefore from the PD-L1 ≥1% cohort.
Primary Outcome(s)
- Primary Outcome(s)
- DFS
- Evaluated Outcome
- DFS
- Form(s)
- Form 1
Outcome Data
- OS Control
- 4-year 70.9%
- OS Gain
- 4-year 8.4%
- OS HR
- Not significant (immature)
- DFS Control
- 3-years 48.2%
- DFS Gain
- 3-years 11.8%
- DFS HR
- 0.66 (0.50-0.88)
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 305
- Scorecard version
- 1
- Issue date
- 01.12.2021
- Last update
- 15.11.2023
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.