4
Indication details
- Combined Agent(s)
- Platinum-based ChT
- Control Arm
- Placebo + Platinum-based ChT
- FDA Therapeutic Indication
- Cemiplimab in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Advanced
- Trial Name
- EMPOWER-Lung 3
- NCT Number
- NCT03409614
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval November 2022
- EMA Approval
- EMA (CHMP) February 2023 EC decision May 2023
- Comment
- EMA approval is for the PD-L1 ≥1% subgroup which does not meet the ESMO-MCBS requirements for subgroups (i.e., exploratory analysis, without multiplicity adjustment), so no score is provided for this subgroup.
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 12.9 months
- OS Gain
- 8.2 months
- OS HR
- 0.65 (0.51-0.82)
Adjustments
- QoL Comment
-
No QoL benefit
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMo-MCBS v1.1
- Scorecard ID
- 397
- Scorecard version
- 1
- Issue date
- 22.09.2023
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.