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Patologi - Biomarker Image Bank

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®.

KEYTRUDA® eligible

Not applicable

NSCLC

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

NSCLC Prevalence 1

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
NSCLC

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

NSCLC Prevalence 2

Details

Sources:

  • Skov BG, et al. Mod Pathol. 2020 Jan;33(1):109-117
NSCLC

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

NSCLC Prevalence 3

Details

Sources:

  • Aggarwal C. et al. Annals of Oncology. 2016 Oct;27(6):359-378
NSCLC

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

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

HNSCC_2_2

Details

Sources:

  • KEYTRUDA (pembrolizumab) SmPC
HNSCC

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

HNSCC_2_1

Details

Sources:

  • Cohen EEW, et al. The Lancet 2018;393(10167):156-167

Esophageal

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

Esophageal

Details

Sources:

  • KEYTRUDA (pembrolizumab) SmPC

TNBC

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

TNBC

Details

Sources:

  • KEYTRUDA (pembrolizumab) SmPC

Urothelial

Urothelian

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

Urothelian

Details

Sources:

  • Balar AV, et al. Lancet Oncol. 2017 Nov;18(11):1483-1492
Urothelian

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

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

CRC

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

CRC

Details

Sources:

  • Dudley JC, et al. Clin Cancer Res 2016;22(4):813-820

Endometrial

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

Endometrial

Details

Sources:

  • Marabelle A, et al. J Clin Oncol. 2019;38:1-10

MSI-H

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.


Du kan läsa mer om KEYTRUDA på fass.se

KEYTRUDA® (pembrolizumab), 25 mg/ml koncentrat till infusionsvätska, lösning. Antineoplastiska medel, PD-1/PDL-1-hämmare, L01FF02, Rx, Subventioneras ej, SPC 07/2022

INDIKATIONER:

Melanom:

Icke‑småcellig lungcancer (NSCLC)
KEYTRUDA som monoterapi är indicerat för behandling av vuxna patienter med:

KEYTRUDA som kombinationsbehandling är indicerat för vuxna patienter med:

Klassiskt Hodgkins lymfom (cHL)

Urotelial cancer

Skivepitelcancer i huvud och hals (HNSCC)

Njurcellscancer (RCC)

Cancer som uppvisar hög mikrosatellitinstabilitet (MSI-H) eller defekt mismatch repair (dMMR)

Kolorektalcancer (CRC)

KEYTRUDA som monoterapi är indicerat för vuxna med CRC som uppvisar MSI-H eller dMMR i följande behandlingslinjer:

Icke-kolorektal cancer

KEYTRUDA som monoterapi är indicerat för behandling av följande tumörer som uppvisar MSI-H eller dMMR hos vuxna med:

Esofaguscancer

Trippelnegativ bröstcancer (TNBC)

Endometriecancer (EC)

Cervixcancer


KONTRAINDIKATIONER: Överkänslighet mot den aktiva substansen eller mot något hjälpämne.

VARNINGAR OCH FÖRSIKTIGHET:

INTERAKTIONER: Användning av systemiska kortikosteroider eller immunsuppressiva läkemedel före start av KEYTRUDA bör undvikas på grund av potentiell påverkan på KEYTRUDA:s farmakodynamiska aktivitet och effekt.

För fullständig information se www.fass.se

SE-KEY-00105 07/2022

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.