PD-L1 IHC Testing
Immune Checkpoint Inhibitors
Overexpression of PD-L1 has been observed in many carcinomas including lung, urothelial, gastroesphageal junction, squamous cell carcinoma of the head and neck (SCCHN), cervical, triple-negative breast cancer (TNBC) and melanoma
Tumor PD-L1 expression levels have been shown to be a predictive marker with response to several anti-PD1 antibodies1,2
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PD-L1 IHC Testing
Immune Checkpoint Inhibitor Therapies
| Biomarker Assay | Cancer Type | Immunotherapy | Scoring Cut-off |
|---|---|---|---|
| PD-L1 DAKO (22C3) Companion Diagnostic Test | First-line treatment locally advanced or metastatic NSCLC | LIBTAYO® (cemiplimab-rwlc) | PD-L1 expression: TPS* ≥50%1 |
| First-line treatment locally advanced or metastatic NSCLC | KEYTRUDA® (pembrolizumab) | PD-L1 expression: TPS* ≥1%2 | |
| Previously treated recurrent or metastatic cervical cancer | PD-L1 expression: CPS◊ ≥1%2 | ||
| First-line treatment metastatic or recurrent SCCHN | PD-L1 expression: CPS◊ ≥1%2 | ||
| Previously treated locally advanced or metastatic esophageal squamous cell carcinoma | PD-L1 expression: CPS◊ ≥10%2 | ||
| In combination with chemotherapy in locally recurrent unresectable or metastatic TNBC | PD-L1 expression: CPS◊ ≥10%2 | ||
| PD-L1 DAKO (28-8) Companion Diagnostic | First-line treatment metastatic NSCLC | OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab) | PD-L1 expression in ≥1% TC¤3 |
| PD-L1 DAKO (28-8) Complementary Diagnostic | Previously treated metastatic non-squamous NSCLC | OPDIVO® (nivolumab) | PD-L1 expression in ≥1% or ≥5% or ≥10% TC¤4 |
| Previously treated recurrent or metastatic SCCHN | PD-L1 expression in ≥1% TC¤4 | ||
| Previously treated locally advanced or metastatic urothelial carcinoma | PD-L1 expression in ≥1% TC¤4 | ||
| PD-L1 VENTANA® (SP263) Companion Diagnostic | Previously treated Stage II to IIIA NSCLC | TECENTRIQ® (atezolizumab) | PD-L1 expression in ≥1% TC5 |
| First-line treatment locally advanced or metastatic NSCLC | LIBTAYO® (cemiplimab-rwlc) | PD-L1 expression in ≥50% TC¤1 |
NSCLC: non-small cell lung cancer
SCCHN: squamous cell carcinoma of the head and neck
TNBC: Triple negative breast cancer
*TPS: tumor proportional score
◊CPS: combined positive score=[# of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total # of viable tumor cells] *100
¤TC: PD-L1 expressing tumor cells
#IC: PD-L1 expressing tumor-infiltrating immune cells
References
1. Kim, JW and Eder, JP, Prospects for Targeting PD-1 and PD-L1 in Various Tumor Types. Available on the website of the Cancer Network. (http://www.cancernetwork.com/ oncology-journal/prospects-targeting-pd-1-and-pd-l1- various-tumor-types). Accessed July 8, 2015.
2. Garon, EB et al., Pembrolizumab for the Treatment of Non-Small-Cell Lung Cancer. N Engl J Med 2015; 372:2018-28.
Table References
1. LIBTAYO (cemiplimab-rwlc) Regeneron Pharmaceuticals, Inc., Tarrytown, NY; 2021.
2. KEYTRUDA® (pembrolizumab) Merck and Co., Inc., Whitehouse Station, NJ; 2023.
3. OPDIVO® (nivolumab) Bristol-Myers Squibb Company, Princeton, NJ; 2019.
4. Agilent website, PD-L1 IHC 28-8 pharmDx for Autostainer Link 48, accessed 11/13/18. https://www.agilent.com/en/product/pharmdx/pd-l1-ihc-28-8-pharmdx/pd-l1-ihc-28-8-pharmdx-for-autostainer-link-48-153940.
5. TECENTRIQ® (atezolizumab) Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA; 2019.