4
Indication details
- Combined Agent(s)
- Durvalumab and platinum-based ChT
- Control Arm
- Platinum-based ChT
- FDA Therapeutic Indication
- EMA: First-line treatment of tremelimumab in combination with durvalumab and platinum-based chemotherapy (ChT) for adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations - FDA: Tremelimumab in combination with durvalumab and platinum-based ChT for adult patients with metastatic NSCLC with no EGFR mutation or ALK genomic tumor aberrations.
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Metastatic
- Trial Name
- POSEIDON
- NCT Number
- NCT03164616
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval November 2022
- EMA Approval
- EMA (CHMP) December 2022 EC decision April 2023
Primary Outcome(s)
- Primary Outcome(s)
- PFS and OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 4.8 months
- PFS Gain
- 1.4 months
- PFS HR
- 0.72 (0.60-0.86)
- OS Control
- 11.7 months
- OS Gain
- 2.3 months 2-year survival gain 10.8%
- OS HR
- 0.77 (0.65-0.92)
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 362
- Scorecard version
- 1
- Issue date
- 01.12.2022
- Last update
- 26.06.2023
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.