4
Indication details
- Control Arm
- Placebo
- FDA Therapeutic Indication
- For the treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD- 1/PD-L1-containing regimen
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Hepatobiliary Cancers - Hepatocellular Carcinoma
- Tumour Stage
- Advanced
- Trial Name
- KEYNOTE-394
- NCT Number
- NCT03062358
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval November 2018
- EMA Approval
- Not EMA approved
- Comment
- The approval was based on the HBV+ patients which correspond to approximately 80% of the overall cohort
Primary Outcome(s)
- Primary Outcome(s)
- OS (ITT)
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 13.0 months
- OS Gain
- 1.6 months. 3-year survival gain>10% (24/300 = 8% at risk at 3 years in the experimental arm)
- OS HR
- 0.79 (0.63-0.99)
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 473
- Scorecard version
- 1
- Issue date
- 20.11.2024
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.