2
Indication details
- Control Arm
- Placebo
- FDA Therapeutic Indication
- Treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma, refractory or not eligible to radioactive iodine who have progressed during or after prior systemic therapy
- Tumour Type
-
Endocrine Tumours
- Tumour Sub-type
- Thyroid cancer - differentiated
- Tumour Stage
- Locally advanced or metastatic
- Trial Name
- COSMIC-311
- NCT Number
- NCT03690388
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval September 2021
- EMA Approval
- EMA (CHMP) March 2022 EC decision June 2022
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 1.9 months
- PFS Gain
- 9.1 months
- PFS HR
- 0.22 (96% CI 0.15-0.32)
Adjustments
- QoL Comment
-
QoL was an exploratory endpoint
- Toxicity Comment
-
Increased toxicity (10% Grade 3 hand-foot syndrome vs 0%, 8% Grade 3 fatigue vs 0%)
Score (after adjustments)
- Preliminary non-curative score
-
3
- Toxicity adjustment
- 1-
- Non-curative score
-
2
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 302
- Scorecard version
- 1
- Issue date
- 25.10.2021
- Last update
- 21.07.2023
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.