3
Indication details
- Control Arm
- Osimertinib
- Therapeutic Indication
- FDA: Amivantamab in combination with lazertinib for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. EMA: Amivantamab in combination with lazertinib is indicated for the first‑line treatment of adult patients with advanced non‑small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
- 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
- NCT Number
- NCT04487080
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval August 2024
- EMA Approval
- EMA (CHMP) November 2024. Pending EC decision
- Comment
- EMA (CHMP) November 2024: Lazertinib received a recommendation on new medicine and Amivantamab received a recommendation on extension.
Primary Outcome(s)
- Primary Outcome(s)
- PFS. OS as secondary endpoint
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 16.6 months
- PFS Gain
- 7.1 months
- PFS HR
- 0.70 (0.58 - 0.85)
- OS HR
- Immature, NS at interim
Adjustments
- QoL Comment
-
QoL data pending
- Toxicity Comment
-
>10% increment in discontinuation due to adverse effects, >30% increment in grade 3-4 AEs impacting on daily well-being
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 464
- Scorecard version
- 1
- Issue date
- 09.10.2024
- Last update
- 18.11.2024
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.