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Find PD-L1 with paired H&E stained digital slides from over 100 cases from multiple tumor types.

Make sure you are logged-in to access the Image Bank and the Self-scoring module to evaluate the expression of PD-L1 in various tumor types.

Overview of testing for KEYTRUDA®

The table below describes the regulatory approved diagnostic-associated indications. Click the tabs to view PD-L1 or MMR/MSI information for determining patient eligibility for treatment with KEYTRUDA®.

Click i in the table below for links to references.

 
KEYTRUDA® eligible
 
Not applicable

Tumor type
Line of
treatment
Regimen Patient population
Scoring algorithm
 
TPS CPS
Approximate PD-L1 prevalence
 

Line:1 Regimen:In combination with chemotherapy Patient population:
Metastatic non-squamous
No EGFR or ALK mutations
i
TPS, CPS:No testing Prevalence
i
 
Line:1 Regimen:In combination with chemotherapy Patient population:
Metastatic squamous
i
TPS, CPS:No testing Prevalence
i
 
Line:1 Regimen:Monotherapy Patient population:
Metastatic non-squamous
No EGFR or ALK mutations
i
TPS:≥50% CPS:  Prevalence
i
 
Line:2 Regimen:Monotherapy Patient population:
Locally advanced (stage IIIB) or metastatic (stage IV) after previous chemotherapy regimen
i
TPS:≥1% CPS:  



 

Line:1 Regimen:Monotherapy Patient population:
Advanced
Unresectable or metastatic
i
TPS, CPS:
No testing
 
 
Line:Adjuvant Regimen:Monotherapy
Patient population:
Stage III with melanoma and lymph node involvement
who have undergone complete resection
i
TPS, CPS:
No testing
 



 

Line:1 Regimen:Monotherapy
or in combination
with chemotherapy
Patient population:
Recurrent or metastatic
i
TPS: CPS:≥1 Prevalence Prevalence
i
 
Line:2 Regimen:Monotherapy Patient population:
Recurrent or metastatic after progression with platinum-based chemotherapy
i
TPS:≥50% CPS:  Prevalence
i





Line:1 Regimen:In combination with
chemotherapy
Patient population:
Locally advanced
unresectable or metastatic
carcinoma or HER-2
negative gastroesophageal
junction adenocarcinoma
i
TPS: CPS:≥10 Prevalence Prevalence
i





Line:1 Regimen:In combination with
chemotherapy
Patient population:
Locally recurrent
unresectable or metastatic
i
TPS: CPS:≥10 Prevalence Prevalence
i



 

Line:1 Regimen:Monotherapy Patient population:
Locally advanced or metastatic
not eligible for cisplatin
i
TPS: CPS:≥10 Prevalence
i
 
Line:2 Regimen:Monotherapy Patient population:
Locally advanced or metastatic after progression with platinum-based chemotherapy
i
TPS, CPS:No testing  



 

Line:1 Regimen:In combination with axitinib Patient population:
Advanced
i
TPS, CPS:
No testing
 



 

Line:3 Regimen:Monotherapy Patient population:
Relapsed or refractory
who have failed autologous stem cell transplant and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV
i
TPS, CPS:
No testing
 



Tumor type
Line of
treatment
Regimen Patient population
Test modality
 
IHC-MMR PCR-MSI
Approximate dMMR/MSI-H prevalence
 

Line:1 Regimen:Monotherapy Patient population:
Metastatic microsatellite
instability-high (MSI-H)
or mismatch repair
deficient (dMMR)
i
TPS:dMMR CPS:MSI-H Prevalence
i



KEYTRUDA® (Pembrolizumab) – UTVALGT SIKKERHETSINFORMASJON


Denne SSI er basert på SPC for Keytruda godkjent 19. oktober 2021

KONTRAINDIKASJONER:
Overfølsomhet overfor virkestoffet (pembrolizumab) eller overfor noen av hjelpestoffene (L-histidin, L-histidinhydroklorid monohydrat, sukrose, polysorbat 80).

FORSIKTIGHET UTVISES VED:
Immunrelaterte bivirkninger: pneumonitt, kolitt, hepatitt, nefritt, binyrebarksvikt, hypotyreose, hypertyreose, tyreoiditt, hypofysitt, type 1 diabetes mellitus, diabetisk ketoacidose, uveitt, artritt, myositt, myokarditt, hjertearytmi (inkludert atrieflimmer), pankreatitt, alvorlige hudreaksjoner inkludert SJS eller TEN, Guillain-Barrès syndrom, myastenisk syndrom, Sjøgrens syndrom, hemolytisk anemi, sarkoidose, encefalitt, myelitt, vaskulitt, skleroserende kolangitt, gastritt, ikke-infeksiøs cystitt og alvorlig infusjonsrelaterte reaksjoner. Immunrelaterte bivirkninger, inkludert alvorlige og fatale tilfeller har forekommet hos pasienter behandlet med pembrolizumab, samt alvorlige og akutte bivirkninger i kombinasjon med kjemoterapi og aksitinib har blitt rapportert i kliniske studier eller markedsføring.

VIKTIGE INTERAKSJONER:
Bruk av systemiske kortikosteroider eller immunsuppressiver før oppstart av pembrolizumab bør unngås på grunn av deres potensielle interferens med den farmakodynamiske aktiviteten og effekten til pembrolizumab. Systemiske kortikosteroider eller andre immunsuppressiver kan imidlertid brukes etter oppstart av behandling med pembroliuzmab for å behandle immunrelaterte bivirkninger. Kortikosteroider kan også brukes som premedisinering, som profylaktisk antiemetika og/eller for å lindre kjemoterapirelaterte bivirkninger ved bruk av pembrolizumab i kombinasjon med kjemoterapi.

Før forskrivning av KEYTRUDA se preparatomtalen.

NO-KEY-00249


PD-L1 interpretation for KEYTRUDA®

Two PD-L1 scoring algorithms exist for determining patient eligibility to Keytruda: TPS and CPS. Whether TPS or CPS is used is linked to each given tumor type and the data from the respective clinical trials.


TPS (Tumor Proportion Score)

tps

Consists of the number of PD-L1 expressing tumor cells (partial or complete membrane staining at any intensity) relative to the total number of viable tumor cells, multiplied by 100.

TPS is represented as a percentage1.


CPS (Combined Positive Score)

cps

Consists of the number of PD-L1 expressing cells (tumor cells, lymphocytes, macrophages) relative to the total number of viable tumor cells, multiplied by 100.

CPS is represented as a number, and even though the result of the calculation can exceed 100, the maximum score is defined as CPS 1002.

Referenser
1. Dako Denmark A/S, PD-L1 IHC 22C3 pharmDx, Interpretation Manual, NSCLC, Version 28.08.2017.
2. Dako Denmark A/S, PD-L1 IHC 22C3 pharmDx, Interpretation Manual, Urothelial Carcinoma, Version 24.08.2018.
NO-KEY-00193 12/2021