3
Indication details
- Combined Agent(s)
- Nab-paclitaxel
- Control Arm
- Placebo + nab-paclitaxel
- FDA Therapeutic Indication
- Treatment of patients with unresectable locally advanced or metastatic TNBC whose tumours have PD-L1 expression ≥1% and who have not received prior ChT for metastatic disease
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Unresectable locally advanced or metastatic
- Tumour Sub-Group
- Triple-negative PD-L1+≥1%
- Trial Name
- IMpassion130
- NCT Number
- NCT02425891
- Trial Phase
- Phase III
Approval details
- FDA Approval
- Not FDA approved
- EMA Approval
- EMA (CHMP) June 2019 EU Decision October 2019
- Comment
- FDA accelerated Approval in March 2019 withdrawn by the FDA August 2021
Primary Outcome(s)
- Primary Outcome(s)
- PFS stratified for PD-L1+
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 5.3 months
- PFS Gain
- 2.2 months
- PFS HR
- 0.63 (0.50-0.80)
- OS Control
- 18.0 months
- OS Gain
- 7.0 months
- OS HR
- 0.71 (0.54-0.94)*
Adjustments
- QoL Comment
-
No QoL benefit
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
- Comment
-
*Exploratory unplanned post hoc analysis not eligible for ESMO-MCBS grading
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 171
- Scorecard version
- 1
- Issue date
- 13.05.2020
- Last update
- 25.04.2024
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.