4
Indication details
- Control Arm
- Vinorelbine or gemcitabine (by investigator choice )
- Therapeutic Indication
- Atezolizumab as monotherapy is indicated for the first-line treatment of adult patients with advanced NSCLC who are ineligible for platinum-based therapy
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Advanced
- Trial Name
- IPSOS
- NCT Number
- NCT03191786
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) positive recommendations on new therapeutic indications, July 2024. EC decision September 2024
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS (ITT)
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 4.0 months
- PFS Gain
- 0.2 months
- PFS HR
- 0.87 (0.70-1.07)
- OS Control
- 9.2 months
- OS Gain
- 1.1 months 2-year survival gain = 11.9% (24.3% vs 12.4%)
- OS HR
- 0.78 (0.63-0.97), P = 0.028
Adjustments
- QoL Comment
-
No QoL benefit
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 458
- Scorecard version
- 1
- Issue date
- 12.09.2024
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.