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