4
Indication details
- Combined Agent(s)
- ChT
- Control Arm
- Placebo plus ChT
- Therapeutic Indication
- Treatment of locally recurrent unresectable or metastaticTNBC in adults whose tumours express PD-L1 with a CPS ≥ 10 and who have not received prior chemotherapy
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Locally recurrent inoperable or metastatic
- Tumour Sub-Group
- Triple-negative, PD-L1 (CPS ≥10)
- Trial Name
- KEYNOTE-355
- NCT Number
- NCT02819518
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA accelerated approval November 2020 regular approval July 2021
- EMA Approval
- EMA (CHMP) September 2021 EC decision October 2021
Primary Outcome(s)
- Primary Outcome(s)
- PFS/OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 5.6 months
- PFS Gain
- 4.1 months
- PFS HR
- 0.66 (0.50-0.88)
- OS Control
- 16.1 months
- OS Gain
- 6.9 months
- OS HR
- 0.73 (0.55-0.95) P = 0.0185 (reached threshold P <0.0227)
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
- 239
- Scorecard version
- 1
- Issue date
- 01.03.2020
- 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.