PD-L1 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 Testing
Immune Checkpoint Inhibitor Therapies
| Sample Type | Drug Under Consideration | PD-L1 Testing |
|---|---|---|
| Cervical Cancer | pembrolizumab | DAKO (22C3) Companion Diagnostic Test1 |
| Espohageal | pembrolizumab | DAKO (22C3) Companion Diagnostic Test1 |
| Gastric / Gastroesophageal Junction (GEJ) Adenocarcinoma | pembrolizumab | DAKO (22C3) Companion Diagnostic Test1 |
| Melanoma | nivolumab | Testing not required |
| Melanoma | pembrolizumab | Testing not required3 |
| NSCLC - Adencocarcinoma | atezolizumab | VENTANA® (SP142) Complementary Diagnostic Test4 |
| NSCLC - Adencocarcinoma | nivolumab | DAKO (28-8) Complimentary Test5-7 |
| NSCLC - Adencocarcinoma | pembrolizumab | DAKO (22C3) Companion Diagnostic Test3 |
| NSCLC - Squamous | atezolizumab | VENTANA® (SP142) Complementary Diagnostic Test4 |
| NSCLC - Squamous | nivolumab | Testing not required6 |
| NSCLC - Squamous | pembrolizumab | DAKO (22C3) Companion Diagnostic Test3 |
| Squamous Cell Carcinoma of the Head and Neck (SCCHN) | nivolumab | DAKO (28-8) Complimentary Test8 |
| Squamous Cell Carcinoma of the Head and Neck (SCCHN) | pembrolizumab | DAKO (22C3) Companion Diagnostic Test1 |
| Triple Negative Breast Cancer (TNBC) | atezolizumab | VENTANA® Companion Diagnostic Test9 |
| Urothelial Carcinoma | atezolizumab | VENTANA® (SP142) Complementary Diagnostic Test9 |
| Urothelial Carcinoma | nivolumab | DAKO (28-8) Complimentary Test8 |
| Urothelial Carcinoma | pembrolizumab | DAKO (22C3) Companion Diagnostic Test1 |
sample type
Cervical Cancer
Drug Under Consideration: pembrolizumab
PD-L1 Testing: DAKO (22C3) Companion Diagnostic Test1
sample type
Espohageal
Drug Under Consideration: pembrolizumab
PD-L1 Testing: DAKO (22C3) Companion Diagnostic Test1
sample type
Gastric / Gastroesophageal
Junction (GEJ) Adenocarcinoma
Drug Under Consideration: pembrolizumab
PD-L1 Testing: DAKO (22C3) Companion Diagnostic Test1
sample type
Melanoma
Drug Under Consideration: nivolumab
PD-L1 Testing: Testing not required
Drug Under Consideration: pembrolizumab
PD-L1 Testing: Testing not required3
sample type
NSCLC - Adencocarcinoma
Drug Under Consideration: atezolizumab
PD-L1 Testing: VENTANA® (SP142) Complementary Diagnostic Test4
Drug Under Consideration: nivolumab
PD-L1 Testing: DAKO (28-8) Complimentary Test5-7
Drug Under Consideration: pembrolizumab
PD-L1 Testing: DAKO (22C3) Companion Diagnostic Test3
sample type
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Drug Under Consideration: nivolumab
PD-L1 Testing: DAKO (28-8) Complimentary Test8
Drug Under Consideration: pembrolizumab
PD-L1 Testing: DAKO (22C3) Companion Diagnostic Test1
sample type
Triple Negative Breast Cancer (TNBC)
Drug Under Consideration: atezolizumab
PD-L1 Testing: VENTANA® Companion Diagnostic Test9
sample type
Urothelial Carcinoma
Drug Under Consideration: atezolizumab
PD-L1 Testing: VENTANA® (SP142) Complementary Diagnostic Test9
Drug Under Consideration: nivolumab
PD-L1 Testing: DAKO (28-8) Complimentary Test8
Drug Under Consideration: pembrolizumab
PD-L1 Testing: DAKO (22C3) Companion Diagnostic Test1
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. Agilent DAKO 22C3 website; https://www.agilent.com/en/product/pharmdx/pd-l1-ihc-22c3-pharmdx/pd-l1-ihc-22c3-pharmdx-for-autostainer-link-48-94449. Accessed 8/4/2021
2. Opdivo® (nivolumab) Bristol-Myers Squibb Company, Princeton, NJ 08543; 2021
3. KEYTRUDA® (pembrolizumab) Merck and Co., Inc., Whitehouse Station, NJ; 2021.
4. VENTANA® PD-L1 (SP142) Assay package insert, 740-4859. 1016217US Rev A.
5. Agilent press release, September 18, 2017. Accessed on the Agilent website 08/23/21. http://www.agilent.com/about/newsroom/presrel/2017/19sep-ca17030.html.
6. TECENTRIQ® (atezolizumab) Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA; 2019.
7. Cancer Research Institute website; https://www.cancerresearch.org/join-the-cause/cancer-immunotherapy-month/30-facts/04. Accessed 8/25/21.