3
ESMO-MCBS v1.1
Scorecard version: 1
Indication details
- Tumour Type
- Refractory NTRK fusion–positive cancers
- Control Arm
- Single arm study
- Treatment Setting
- For treatment of patients with refractory NTRK fusion–positive cancers who are locally advanced, metastatic or where surgical resection is likely to result in severe morbidity and who have no satisfactory treatment options.
- Trial Name
- NAVIGATE
Primary Outcome(s)
- Primary Outcome(s)
- RR
- Form(s)
- Form 3
Outcome Data
- RR Gain
- 75% (independent review)
- DoR
- 9+ 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 - Issue date
- 20.12.2019
- Release date
- 20.12.2019
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