3
ESMO-MCBS v1.1
Scorecard version: 1
Indication details
- Tumour Type
- Thoracic Malignancies
- Tumour Sub-type
- Non-small-cell Lung Cancer
- Tumour Sub-Group
- RET fusion-positive
- Tumour stage
- Advanced
- Control Arm
- Single arm (Phase I/II)
- Treatment Setting
- Treatment of adults with advanced RET fusion positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor
- Trial Name
- LIBRETTO-001
Primary Outcome(s)
- Primary Outcome(s)
- ORR
- Evaluated Outcome
- ORR
- Form(s)
- Form 3
Outcome Data
- PFS Control
- 22.0 months
- ORR
- 84%
- DoR
- 20.2 months
- QoL Comment
- QoL evaluated as an exploratory endpoint
Final Score (after adjustments)
- Preliminary non-curative score
- 3
- Final non-curative Score
- 3
- Comment
- EMA (CHMP) April 2022 EC Decision June 2022
FDA approval May 2020 FDA regular approval September 2022 - Issue date
- 31.05.2022
- Release date
- 31.05.2022
- Last update
- 26.01.2023
ChT; chemotherapy; DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; FFS, failure-free survival; HR, hazard ratio; iDFS, invasive disease-free survival; ITT, intention to treat; MFS, metastasis-free survival; ORR, overall response rate; OS, overall survival; pCR, pathologic complete response/remission; PE, point estimate; PFS, progression-free survival; QoL, quality of life; RFS, relapse-free survival; RR, response rate; SD, stable disease; SSA, somatostatin analogue; SSTR, somatostatin receptor; TKI, tyrosine kinase inhibitor, TTP, time to progression