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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 12 years of age and older with solid tumours expressing 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 not received a prior NTRK inhibitor, and who have no satisfactory treatment options
Trial Name
STARTRK-1; STARTRK-2; ALKA-372-001

Primary Outcome(s)

Primary Outcome(s)
ORR,DOR
Evaluated Outcome
ORR,DOR
Form(s)
Form 3

Outcome Data

PFS Control
11.2 months
ORR
57%
DoR
10.4 months

Final Score (after adjustments)

Preliminary non-curative score
3
Final non-curative Score
3
Comment
EMA (May 2020) EC decision July 2020
FDA approval August 2019
Issue date
23.07.2020

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; 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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