3
Scorecard version: 1
Indication details
- Tumour Type
- Brain Tumours
- Tumour Sub-type
- Glioma (high grade)
- Tumour Sub-Group
- BRAF V600E
- Tumour stage
- Unresectable or metastatic
- Control Arm
- Single arm (Phase II)
- Treatment Setting
- For the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options
- Trial Name
- ROAR
Primary Outcome(s)
- Primary Outcome(s)
- Investigator-assessed ORR
- Evaluated Outcome
- ORR
- Form(s)
- Form 3
Outcome Data
- PFS Control
- 3.8 months
- ORR
- 33%
- DoR
- 36.9 months
Final Score (after adjustments)
- Preliminary non-curative score
- 3
- Final non-curative Score
- 3
- Comment
- FDA accelerated approval June 2022
- Issue date
- 07.09.2022
- Release date
- 07.09.2022
ChT; chemotherapy; DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; FFS, failure-free survival; HR, hazard ratio; HRD, homologus recombination deficiency; HRP, homologous recombination proficient; iDFS, invasive disease-free survival; ITT, intention to treat; MFS, metastasis-free survival; NS, not significant; 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; rPFS, radiographic progression-free survival; SD, stable disease; SSA, somatostatin analogue; SSTR, somatostatin receptor; TKI, tyrosine kinase inhibitor, TTP, time to progression; WT, wild type