3
Indication details
- Combined Agent(s)
- Palbociclib + fulvestrant
- Control Arm
- Placebo + palbociclib + fulvestrant
- Therapeutic Indication
- Inavolisib with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant endocrine therapy.
- Tumour Sub-type
- Breast Cancer
- Tumour Stage
- Locally advanced or metastatic
- Tumour Sub-Group
- PIK3CA-mut, HR+, HER2-
- Trial Name
- INAVO120
- NCT Number
- NCT04191499
- Trial Phase
- Phase II/III
Approval details
- FDA Approval
- FDA approval October 2024
Primary Outcome(s)
- Primary Outcome(s)
- PFS. OS as secondary endpoint
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 7.3 months
- PFS Gain
- 7.7 months
- PFS HR
- 0.43 (0.32-0.59) P<0.001
- OS Control
- 31.1 months
- OS Gain
- 17.5 months (estimated)
- OS HR
- 0.64 (0.43-0.97) interim OS gain not significant
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 475
- Scorecard version
- 1
- Issue date
- 22.11.2024
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.