1
Indication details
- Control Arm
- Placebo
- Therapeutic Indication
- As monotherapy for the treatment of adult patients with advanced or unresectable HCC who have serum AFP of ≥ 400 ng/ml and who have been previously treated with sorafenib
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Hepatobiliary Cancers - Hepatocellular Carcinoma
- Tumour Stage
- Advanced or unresectable
- Trial Name
- REACH-2
- NCT Number
- NCT02435433
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval May 2019
- EMA Approval
- EMA (CHMP) June 2019 EC decision August 2019
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 7.3 months
- OS Gain
- 1.2 months
- OS HR
- 0.71 (0.53 -0.95)
Adjustments
- QoL Comment
-
Benefit for delayed deterioration in global QoL not significant
Score (after adjustments)
- Preliminary non-curative score
-
1
- Non-curative score
-
1
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 140
- Scorecard version
- 1
- Issue date
- 04.12.2019
- 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.