3
Indication details
- Combined Agent(s)
- Cisplatin
- Control Arm
- Cisplatin
- Therapeutic Indication
- In combination with cisplatin for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Pleural mesothelioma
- Tumour Stage
- Unresectable malignant
- Trial Name
- EMPHACIS
- NCT Number
- NCT00005636
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval February 2004
- EMA Approval
- EMA (CHMP) September 2015 EC decision November 2015
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 9.3 months
- OS Gain
- 2.8 months
- OS HR
- 0.77 PE HR (Imputed score assuming the lower limit of the 95%CI was <0.65)
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
- Comment
-
EMA (CHMP) September 2015 EC decision November 2015
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 283
- Scorecard version
- 1
- Issue date
- 22.07.2021
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.