1
Indication details
- Combined Agent(s)
- Pemetrexed + platinum-based Cht
- Control Arm
- Pemetrexed + platinum-based Cht
- Therapeutic Indication
- FDA: Pembrolizumab with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM). EMA: Pembrolizumab, in combination with pemetrexed and platinum chemotherapy, is indicated for the first‑line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma.
- Tumour Type
-
Thoracic Malignancies
- Tumour Sub-type
- Pleural mesothelioma
- Tumour Stage
- Unresectable advanced or metastatic
- Trial Name
- KEYNOTE-483
- NCT Number
- NCT02784171
- Trial Phase
- Phase II/III
Approval details
- FDA Approval
- FDA approval September 2024
- EMA Approval
- EMA (CHMP) November 2024. Pending EC decision (recommendations on extensions)
Primary Outcome(s)
- Primary Outcome(s)
- OS. PFS as secondary to be tested if OS is significant
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 7.16 months
- PFS Gain
- -0.03 months
- PFS HR
- 0.80 (0.65-0.99) p=0.0372
- OS Control
- 16.1 months
- OS Gain
- 1.2 months
- OS HR
- 0.79 (0.64-0.98) p=0.0324
Adjustments
- QoL Comment
-
QoL data pending
- Toxicity Comment
-
Discontinuation due to AEs: 37% in the pembrolizumab group (16% related to pembrolizumab) and 20% in the chemotherapy group
Score (after adjustments)
- Preliminary non-curative score
-
1
- Non-curative score
-
1
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 472
- Scorecard version
- 1
- Issue date
- 08.11.2024
- Last update
- 19.11.2024
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.