4
Indication details
- Control Arm
- Sorafenib
- Therapeutic Indication
- Durvalumab as monotherapy indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC)
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Hepatobiliary Cancers - Hepatocellular Carcinoma
- Tumour Stage
- Advanced or unresectable
- Trial Name
- HIMALAYA
- NCT Number
- NCT03298451
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval November 2023
- EMA Approval
- EMA (CHMP) October 2023 pending EC decision
Primary Outcome(s)
- Primary Outcome(s)
- OS non-inferiority, inferiority margin: 1.08
- Evaluated Outcome
- OS non-inferiority
- Form(s)
- Form 2c
Outcome Data
- OS HR
- 0.86 (0.73 - 1.03)
- ORR
- 17.00%
- DoR
- 16.8 months
Adjustments
- QoL Comment
-
QoL was one of the secondary endpoints. Time to deterioration of global QoL significantly improved HR 0.77 (95%CI 0.62-0.96)
- Toxicity Comment
-
Statistically significantly less toxicities affecting the daily well-being (considering as such: diarrhea, constipation, abdominal pain, nausea, pruritus, decreased appetite, asthenia, fatigue, pyrexia and cough we have 28/388 AEs in durvalumab vs 54/374 AEs in sorafenib, Fisher's exact p=0.0015)
- QoL or Toxicity non-inferiority or superiority in PFS/OS
- Improved global quality of life and toxicity
Final Score (after adjustments)
- Preliminary non-curative score
-
4
- Final non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 419
- Scorecard version
- 1
- Issue date
- 16.01.2024
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.