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3
ESMO-MCBS v1.1
Scorecard version: 1

Indication details

Tumour Type
Skin Cancers
Tumour Sub-type
Cutaneous Squamous Cell Carcinoma
Tumour stage
Recurrent or metastatic
Control Arm
Single arm (Phase II)
Treatment Setting
For patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
Trial Name
KEYNOTE-629

Primary Outcome(s)

Primary Outcome(s)
ORR
Evaluated Outcome
DoR
Form(s)
Form 3

Outcome Data

PFS Control
5.7 months
ORR
35.2%
DoR
>9 months
QoL Comment
Exploratory data only suggest improvement

Final Score (after adjustments)

Final non-curative Score
3
Comment
FDA approval June 2020
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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