3
Indication details
- Control Arm
- Single arm
- FDA Therapeutic Indication
- Afamitresgene autoleucel, a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy, for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices
- Tumour Type
-
Sarcoma
- Tumour Sub-type
- Soft tissue - synovial sarcoma
- Tumour Stage
- Unresectable or metastatic
- Tumour Sub-Group
- HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and MAGE-A4 Ag positive
- Trial Name
- SPEARHEAD-1
- NCT Number
- NCT04044768
- Trial Phase
- Phase II
Approval details
- FDA Approval
- FDA accelerated approval, August 2024
Primary Outcome(s)
- Primary Outcome(s)
- ORR (RECIST v1.1 by IR), DOR. OS as secondary endpoint
- Evaluated Outcome
- ORR
- Form(s)
- Form 3
Outcome Data
- PFS Control
- 3.8 months
- ORR
- 39%
- DoR
- 11.6 months
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 462
- Scorecard version
- 1
- Issue date
- 09.10.2024
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.