3
Indication details
- Combined Agent(s)
- Carboplatin + Pemetrexed
- Control Arm
- Carboplatin + Pemetrexed
- Therapeutic Indication
- Amivantamab in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI).
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Locally advanced or metastatic
- Tumour Sub-Group
- EGFR Exon 19 deletions or Exon 21 L858R substitution mutations
- Trial Name
- MARIPOSA-2
- NCT Number
- NCT04988295
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval September 2024
- EMA Approval
- EMA (CHMP) approved July 2024. EC decision August 2024
- Comment
- Change in marketing authorisation 14 November 2024
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 4.2 months
- PFS Gain
- 2.1 months
- PFS HR
- 0.48 (0.36-0.64)
- OS HR
- 0.77 (0.49-1.21) Interim analysis
Adjustments
- QoL Comment
-
QoL data pending
- Toxicity Comment
-
>10% discontinuations 18 vs 4 %
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 457
- 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.