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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

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