4
ESMO-MCBS v1.1
Scorecard version: 1
Indication details
- Tumour Type
- Skin Cancers
- Tumour Sub-type
- Cutaneous Squamous Cell Carcinoma
- Tumour stage
- Locally advanced or metastatic
- Control Arm
- Single arm (Phase II)
- Treatment Setting
- For the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation
- Trial Name
- R2810-ONC-1423/R2810-ONC-1540
Primary Outcome(s)
- Primary Outcome(s)
- ORR
- Evaluated Outcome
- ORR, DOR
- Form(s)
- Form 3
Outcome Data
- ORR
- 46.1%
- DoR
- >12 months
- QoL Comment
- QoL improved
Final Score (after adjustments)
- Preliminary non-curative score
- 3
- QoL adjustment
- 1+
- Final non-curative Score
- 4
- Comment
- EMA (CHMP) April 2019 EC decision June 2019
FDA approval September 2018 - Issue date
- 22.11.2022
- Release date
- 22.11.2022
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