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3
ESMO-MCBS v1.1
Scorecard version: 1

Indication details

Tumour Type
Gastrointestinal Cancers
Tumour Sub-type
Biliary tract cancer
Tumour Sub-Group
dMMR or MSI-H
Tumour stage
Unresectable or metastatic
Control Arm
Single arm cohort study (Phase II)
Treatment Setting
Treatment of MSI-H or dMMR tumours in adults with unresectable or metastatic biliary cancer, who have disease progression on or following at least one prior therapy.
Trial Name
KEYNOTE-158

Primary Outcome(s)

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

Outcome Data

PFS Control
4.2 months
OS Control
24.3 months
ORR
40.90%
DoR
Not reached (range:4.1-24.9)

Final Score (after adjustments)

Preliminary non-curative score
3
Final non-curative Score
3
Comment
EMA (CHMP) March 2022 EC decision May 2022
Issue date
28.04.2022
Release date
28.04.2022
Last update
12.05.2023

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

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