3
ESMO-MCBS v1.1
Scorecard version: 1
Indication details
- Tumour Type
- Refractory NTRK fusion–positive cancers
- Tumour Sub-Group
- NTRK gene fusion
- Tumour stage
- Locally advanced or metastatic
- Control Arm
- Single arm trials (Phase I/II)
- Treatment Setting
- Adult and paediatric patients with solid tumours that display an NTRK gene fusion, who have disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options
- Trial Name
- SCOUT and NAVIGATE
Primary Outcome(s)
- Primary Outcome(s)
- ORR
- Evaluated Outcome
- ORR
- Form(s)
- Form 3
Outcome Data
- PFS Control
- 28.3 months
- RR Gain
- 79%
- DoR
- 35.2 months
Final Score (after adjustments)
- Preliminary non-curative score
- 3
- Final non-curative Score
- 3
- Comment
- EMA (CHMP) July 2019
EMA conditional marketing authorisation September 2019
FDA accelerated approval November 2019 - Issue date
- 20.12.2019
- Release date
- 20.12.2019
- Last update
- 22.10.2021
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