2
Indication details
- Control Arm
- Placebo
- Therapeutic Indication
- Vimseltinib for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
- Tumour Type
-
Non-cancerous soft-tissue tumour
- Tumour Sub-type
- Tenosynovial giant cell tumour
- Trial Name
- MOTION
- NCT Number
- NCT05059262
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval February 2025
Primary Outcome(s)
- Primary Outcome(s)
- RR. QoL as secondary endpoint
- Evaluated Outcome
- RR
- Form(s)
- Form 2c
Outcome Data
- RR Gain
- 40% (Vimseltinib 40% vs. placebo 0%)
Adjustments
- QoL Comment
-
Reviewed, but not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Preliminary non-curative score
-
2
- Non-curative score
-
2
- Comment
-
QoL data under review March 2025
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 493
- Scorecard version
- 1
- Issue date
- 07.04.2025
- Last update
- 28.04.2025
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.