5
Indication details
- Combined Agent(s)
- Bevacizumab
- Control Arm
- Sorafenib
- FDA Therapeutic Indication
- Advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Hepatobiliary Cancers - Hepatocellular Carcinoma
- Tumour Stage
- Advanced or unresectable
- Trial Name
- IMbrave150
- NCT Number
- NCT03434379
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval May 2020
- EMA Approval
- EMA (CHMP) September 2020 EC decision February 2021
Primary Outcome(s)
- Primary Outcome(s)
- PFS/OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 4.3 months
- PFS Gain
- 2.6 months
- PFS HR
- 0.65 (0.53-0.81)
- OS Control
- 13.4 months
- OS Gain
- 5.8 months
- OS HR
- 0.66 (0.45-0.85)
Adjustments
- QoL Comment
-
Delayed deterioration
Score (after adjustments)
- Preliminary non-curative score
-
4
- QoL adjustment
- 1+
- Non-curative score
-
5
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 215
- Scorecard version
- 1
- Issue date
- 26.10.2020
- Last update
- 15.06.2023
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.