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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

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