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
- 19.4 months
- ORR
- 40.90%
- DoR
- 30.6 months
- QoL Comment
- QoL was not a prespecified endpoint
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
- 28.03.2023
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