4
Indication details
- Control Arm
- Either irinitecan or paclitaxel (Phase II)
- Treatment setting
- Treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma in patients who have received a prior trastuzumab-based regimen
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Gastric or gastroesophageal junction adenocarcinoma
- Tumour Stage
- Locally advanced or metastatic
- Tumour Sub-Group
- HER2+
- Trial Name
- DESTINIY-Gastric01
- NCT Number
- NCT03329690
- Trial Phase
- Phase II
Approval details
- FDA Approval
- FDA approval January 2021
- EMA Approval
- EMA (CHMP) November 2022 EC decision January 2023
Primary Outcome(s)
- Primary Outcome(s)
- ORR, hierarchically: OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 8.4 months
- OS Gain
- 4.1 months
- OS HR
- 0.59 (0.39-0.88)
- ORR
- 51% vs 14% (p<0.001)
Final Score (after adjustments)
- Preliminary non-curative score
-
4
- Final non-curative score
-
4
- Comment
-
EMA (CHMP) November 2022 EC decision February 2023
FDA approval January 2021
FDA approval is based on a study of patients previously treated with ≥2 prior regimens including trastuzumab.
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 243
- Scorecard version
- 1
- Issue date
- 01.03.2021
- Last update
- 14.11.2022
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.