A
Indication details
- Combined Agent(s)
- Platinum-containing ChT
- Control Arm
- Placebo + platinum-containing ChT
- FDA Therapeutic Indication
- Pembrolizumab with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC)
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Early stage resectable neoadjuvant
- Trial Name
- KEYNOTE-671
- NCT Number
- NCT03425643
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval October 2023
- EMA Approval
- EMA (CHMP) February 2024. EC decision April 2024.
Primary Outcome(s)
- Primary Outcome(s)
- EFS
- Evaluated Outcome
- EFS
- Form(s)
- Form 1
Outcome Data
- EFS control
- 17 months - 2-year 40.6%
- EFS gain
- 12.3 months estimated - 2-year 21.8%
- EFS HR
- 0.58 (0.46-0.72)
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 402
- Scorecard version
- 1
- Issue date
- 20.11.2023
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.