5
Indication details
- Combined Agent(s)
- Durvalumab
- Control Arm
- Sorafenib
- FDA Therapeutic Indication
- EMA: Treatment for adult patients in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma - FDA: Treatment for adult patients in combination with durvalumab with unresectable hepatocellular carcinoma
- 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 October 2022
- EMA Approval
- EMA (CHMP) December 2022 EC approval April 2023
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 13.8 months
- OS Gain
- 2.6 months. 3-year survival gain 10.9%. (103/393 = 26% at risk at 3 years in the experimental arm)
- OS HR
- 0.78 (0.67 - 0.92)
Adjustments
- QoL Comment
-
Delayed deterioration in global QoL
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
- 358
- Scorecard version
- 1
- Issue date
- 17.11.2022
- Last update
- 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.