A
Indication details
- Combined Agent(s)
- Platinum-doublet ChT
- Control Arm
- Platinum-doublet ChT
- Therapeutic Indication
- Treatment of adult patients with resectable non-small cell lung cancer in the neoadjuvant setting
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Neoadjuvant
- Trial Name
- CHECKMATE-816
- NCT Number
- NCT02998528
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval March 2022
- EMA Approval
- EMA (CHMP) May 2023 EC decision July 2023
- Comment
- EMA approval is limited to patients whose tumours express PD-L1 on ≥1% of tumour cells. This approval was based on an analysis that does not meet the ESMO-MCBS requirements for subgroups (i.e. many subgroups and without adjustment) and so cannot be scored. Data shown are therefore from the overall population across all PD-L1 categories.
Primary Outcome(s)
- Primary Outcome(s)
- co-primary EFS, pCR
- Evaluated Outcome
- EFS
- Form(s)
- Form 1
Outcome Data
- OS HR
- Not mature
- pCR Control
- 2.2%
- pCR Gain
- 21.8%
- EFS control
- 20.8 months - 2-year 45.3%
- EFS gain
- 20.8 months - 2-year 45.3%
- EFS HR
- 0.63 (97.38% CI, 0.43-0.91)
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
- 340
- Scorecard version
- 1
- Issue date
- 30.05.2022
- 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.