2
Indication details
- Combined Agent(s)
- Oxaliplatin, fluorouracil, and leucovorin
- Control Arm
- Nab-paclitaxel + gemcitabine
- FDA Therapeutic Indication
- Irinotecan liposome with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma.
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Pancreatic cancer
- Tumour Stage
- Metastatic
- Trial Name
- NAPOLI 3
- NCT Number
- NCT04083235
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval February 2024
- EMA Approval
- EMA (CHMP) March 2024. EC decision May 2024
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 5.6 months
- PFS Gain
- 1.8 months
- PFS HR
- 0.69 (0.58-0.83)
- OS Control
- 9.2 months
- OS Gain
- 1.9 months
- OS HR
- 0.83 (0.70-0.99)
- ORR
- 5.60%
Adjustments
- QoL Comment
-
QoL was not a prespecified endpoint
- Toxicity Comment
-
>20% increase in grade 3-4 toxicities impacting daily life
Score (after adjustments)
- Preliminary non-curative score
-
2
- Non-curative score
-
2
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 431
- Scorecard version
- 1
- Issue date
- 22.03.2024
- Last update
- 18.09.2024
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.