2
Indication details
- Control Arm
- Single arm
- FDA Therapeutic Indication
- Monotherapy indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Gastric or gastroesophageal junction adenocarcinoma
- Tumour Stage
- Advanced
- Tumour Sub-Group
- HER2+
- Trial Name
- DESTINY-Gastric02
- NCT Number
- NCT04014075
- Trial Phase
- Phase II
Approval details
- FDA Approval
- FDA approval January 2021
- EMA Approval
- EMA (CHMP) November 2022 EC decision January 2023
- Comment
- FDA approval is based on DESTINY-Gastric01, a study of patients previously treated with ≥2 prior regimens including trastuzumab - EMA approval is based on DESTINY-Gastric01 and DESTINY-Gastric02
Primary Outcome(s)
- Primary Outcome(s)
- ORR DOR
- Evaluated Outcome
- ORR
- Form(s)
- Form 3
Outcome Data
- PFS Control
- 5.6 months
- ORR
- 42%
- DoR
- 8.1 months
Adjustments
- Toxicity Comment
-
QoL was not a prespecified endpoint
Score (after adjustments)
- Preliminary non-curative score
-
2
- Non-curative score
-
2
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 398
- Scorecard version
- 1
- Issue date
- 22.09.2023
- Last update
- 28.11.2023
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.