3
Indication details
- Combined Agent(s)
- Bacillus Calmette-Guérin (BCG)
- Control Arm
- Single arm
- Therapeutic Indication
- Nogapendekin alfa inbakicept-pmln with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors (Ta/T1; Cohort A)
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Urothelial Carcinoma (NMIBC)
- Tumour Sub-Group
- BCG-unresponsive
- Trial Name
- QUILT-3.032
- NCT Number
- NCT0302285
- Trial Phase
- Phase II/III
Approval details
- FDA Approval
- FDA approval April 2024
Primary Outcome(s)
- Primary Outcome(s)
- CR, DSF
- Evaluated Outcome
- ORR
- Form(s)
- Form 3
Outcome Data
- PFS Control
- NR
- ORR
- 71% (Cohort A)
- DoR
- 26.6 months (9.9-NR) (Cohort A)
Adjustments
- QoL Comment
-
Reviewed, but not qualified for an ESMO-MCBS credit
Final Score (after adjustments)
- Preliminary non-curative score
-
3
- Final non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 440
- Scorecard version
- 1
- Issue date
- 27.05.2024
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.