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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®.
KEYTRUDA® eligible
Not applicable
NSCLC
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the firstline treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations.
Source: KEYTRUDA (pembrolizumab) SmPC
Test modality
TPS
No testing
CPS
No testing
Approximate PD-L1 prevalence
Details
Sources:
- Garon EB, et al. N Engl J Med 2015;372(21):2018–28
- Reck M, et al. N Engl J Med 2016;10(2):93–105
- Gandhi L, et al. N Engl J Med 2018;378(22):2078–92
- Paz-Ares L, et al. N Engl J Med 2018;379(21):2040–51
KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adults.
Source: KEYTRUDA (pembrolizumab) SmPC
Test modality
TPS
No testing
CPS
No testing
Approximate PD-L1 prevalence
Details
Sources:
- Skov BG, et al. Mod Pathol. 2020 Jan;33(1):109-117
KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.
Source: KEYTRUDA (pembrolizumab) SmPC
Test modality
TPS
≥50%
CPS
–
Approximate PD-L1 prevalence
Details
Sources:
- Aggarwal C. et al. Annals of Oncology. 2016 Oct;27(6):359-378
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 with a ≥ 1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA.
Source: KEYTRUDA (pembrolizumab) SmPC
Test modality
TPS
≥1%
CPS
–
HNSCC
KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS ≥ 1.
Source: KEYTRUDA (pembrolizumab) SmPC
Test modality
TPS
–
CPS
≥1
Approximate PD-L1 prevalence
Details
Sources:
- KEYTRUDA (pembrolizumab) SmPC
KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy
Source: KEYTRUDA (pembrolizumab) SmPC
Test modality
TPS
≥50%
CPS
–
Approximate PD-L1 prevalence
Details
Sources:
- Cohen EEW, et al. The Lancet 2018;393(10167):156-167
Esophageal
KEYTRUDA, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastroesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 10
Source: KEYTRUDA (pembrolizumab) SmPC
Test modality
TPS
–
CPS
≥10
Approximate PD-L1 prevalence
Details
Sources:
- KEYTRUDA (pembrolizumab) SmPC
TNBC
KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease
Source: KEYTRUDA (pembrolizumab) SmPC
Test modality
TPS
–
CPS
≥10
Approximate PD-L1 prevalence
Details
Sources:
- KEYTRUDA (pembrolizumab) SmPC
Urothelial
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10
Source: KEYTRUDA (pembrolizumab) SmPC
Test modality
TPS
–
CPS
≥10
Approximate PD-L1 prevalence
Details
Sources:
- Balar AV, et al. Lancet Oncol. 2017 Nov;18(11):1483-1492
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy
Source: KEYTRUDA (pembrolizumab) SmPC
Test modality
TPS
No testing
CPS
No testing
Cervical
KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS ≥ 1.
Source: KEYTRUDA (pembrolizumab) SmPC
Test modality
TPS
–
CPS
≥1
Approximate PD-L1 prevalence
Details
Sources:
CRC
KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in adults
Source: KEYTRUDA (pembrolizumab) SmPC
Test modality
IHC-MMR
dMMR
PCR-MSI
MSI-H
Approximate dMMR/MSI-H prevalence
Details
Sources:
- Dudley JC, et al. Clin Cancer Res 2016;22(4):813-820
Endometrial
KEYTRUDA as monotherapy is indicated for the treatment of the following MSI-H or dMMR tumours in adults with advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation.
Source: KEYTRUDA (pembrolizumab) SmPC
Test modality
IHC-MMR
dMMR
PCR-MSI
MSI-H
Approximate dMMR/MSI-H prevalence
Details
Sources:
- Marabelle A, et al. J Clin Oncol. 2019;38:1-10
MSI-H
KEYTRUDA as monotherapy is indicated for the treatment of the following MSI-H or dMMR tumours in adults with unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.
Source: KEYTRUDA (pembrolizumab) SmPC
Test modality
IHC-MMR
dMMR
PCR-MSI
MSI-H
PD-L1 or MMR/MSI testing is not required for use of pembrolizumab in metastatic or adjuvant melanoma, relapsed or refractory classical Hodgkin lymphoma, and advanced or adjuvant renal cell carcinoma. For more detalis see all indication descriptions below.
For mer informasjon om Keytruda, klikk her.
Før forskrivning – se preparatomtalen.
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)
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)
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.
Referanser
- Dako Denmark A/S, PD-L1 IHC 22C3 pharmDx, Interpretation Manual, NSCLC, Version 28.08.2017.
- Dako Denmark A/S, PD-L1 IHC 22C3 pharmDx, Interpretation Manual, Urothelial Carcinoma, Version 24.08.2018.
