4
Indication details
- Control Arm
- Placebo
- Therapeutic Indication
- Treatment of adult patients with unresectable, stage III NSCLC whose disease has not progressed following concurrent platinum-based CRT
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Locally advanced
- Tumour Sub-Group
- PD-L1
- Trial Name
- PACIFIC
- NCT Number
- NCT02125461
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval February 2018
- EMA Approval
- EMA CHMP July 2018 EC decision September 2018
- Comment
- EMA approval is limited to patients whose tumours express PD-L1 on ≥1% of tumour cells. This approval was based on findings from a post hoc analysis indicating a lack of benefit for patients whose tumours express PD-L1 on <1% of tumour cells.12 Data shown are therefore from the ITT population across all PD-L1 categories
Primary Outcome(s)
- Primary Outcome(s)
- PFS ITT population across all PD-L1 categories
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 5.6 months
- PFS Gain
- 11.3 months
- PFS HR
- 0.45 (0.44-0.68)
- OS Control
- 29.1 months
- OS Gain
- 18.4 months
- OS HR
- 0.72 (0.59-0.89)
Adjustments
- QoL Comment
-
No QoL benefit
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
- 170
- Scorecard version
- 1
- Issue date
- 27.04.2020
- Last update
- 15.11.2023
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.