4
Indication details
- Control Arm
- Placebo
- FDA Therapeutic Indication
- FDA: Osimertinib for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. EMA: Osimertinib for adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum based chemoradiation therapy.
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Stage
- Locally advanced, unresectable
- Tumour Sub-Group
- EGFR exon 19 deletions or exon 21 L858R mutations
- Trial Name
- LAURA
- NCT Number
- NCT03521154
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval September 2024
- EMA Approval
- EMA (CHMP) approved November 2024. Pending EC decision
Primary Outcome(s)
- Primary Outcome(s)
- PFS. OS as secondary endpoint
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 5.6 months
- PFS Gain
- 33.5 months
- PFS HR
- 0.16 (0.10-0.24) P<0.001
- OS HR
- 0.81 (0.42 - 1.56) P = 0.53. Interim analysis (maturity, 20%), immature
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Preliminary non-curative score
-
3
- Long-term plateau in the PFS curve
- 1+
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 471
- Scorecard version
- 1
- Issue date
- 08.11.2024
- 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.