PD-L1 by IHC, Opdivo®

PD-L1 by IHC, Opdivo®

Programmed death 1 (PD-1) is an immune inhibitory receptor expressed on the surface of activated T-cells and mediates suppression of the immune system.1 PD-1 interacts with the immunosuppressive PD-L1 ligand which is expressed on tumor cells, inflammatory cells, and histiocytes, and inhibits T-cell activation.2 A new class of immunotherapies, PD-1 and PD-L1 inhibitors, blocks the interaction between PD-1 and PD-L1 on the tumor cells and can enhance T-cell responses and mediate anti-tumor activity.1,2

Methodology

Immunohistochemistry (IHC)

Turnaround Time

2-3 days

CPT

Call client services

Disease

Non-Small-Cell Lung Cancer (NSCLC)

Lung Cancer

Bladder Cancer

Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Specimen

Tissue

Volume

One formalin-fixed paraffin-embedded (FFPE) tissue block or five unstained positively charged slides sectioned from FFPE tissue block at 4 to 5 microns.

Container

Formalin-fixed, paraffin-embedded (FFPE) tissue blocks or slides

Collection

Tissue should be fixed in 10% neutral buffered formalin for no more than 72 hours, embed in paraffin. Alternative fixatives have not been validated and may give erroneous results.

Special Instructions

Global only

Causes for Rejection

Insufficient tissue; tumor other than nonsquamous non−small-cell lung cancer

Storage Instructions

Room temperature

Test Includes

Includes technical and professional components

Use Statement

Non-Small Cell Lung Cancer (NSCLC)
PD-L1 expression is associated with the approval of OPDIVO® (nivolumab) for the treatment of patients with previously-treated non-small cell lung cancer (NSCLC).The DAKO PD-L1 IHC 28-8 pharmDxTM is a complementary diagnostic test to detect PD-L1 protein expression levels, and although not required, is a tool that helps physicians determine which patients may benefit most from treatment. In the CheckMate 057 trial PD-L1 expression was associated with improved efficacy across all endpoints (OS, PFS, duration of response) at all expression levels. The most improvement was seen in patients with PD-L1 expression ≥5% and ≥10%, but was evident at PD-L1 expression levels as low as ≥1%. Patients with tumors that had PD-L1 expression levels ≥1% were associated with a doubling of overall median survival.

 

Squamous Cell Carcinoma of the Head and Neck (SCCHN)

The efficacy of OPDIVO was evaluated in the Checkmate 141 trial of 361 patients with recurrent or metastatic SCCHN who had experienced disease progression during or within 6 months of receiving platinum-based chemotherapy. 

The PD-L1 IHC 28-8 pharmDx assay is approved as a complementary diagnostic test for use with previously treated patients with recurrent or metastatic SCCHN.  PD-L1 expression ≥1% may be associated with enhanced survival from OPDIVO.  While OPDIVO is approved for this indication without the use of the test, the test provides physician with important information about those patients who are most likely to respond positively to OPDIVO.

 

Urothelial Carcinoma (Bladder Cancer)

The efficacy of OPDIVO was evaluated in the Checkmate 275 trial of patients with locally advanced or metastatic bladder cancer who had disease progression within 12 months of receiving platinum-based chemotherapy. 

The PD-L1 IHC 28-8 pharmDx assay is approved as a complementary diagnostic test for use with previously treated patients with locally advanced or metastatic bladder cancer.  PD-L1 expression ≥1% may be associated with enhanced response rate from OPDIVO.  While OPDIVO is approved for this indication without the use of the test, the test provides physician with important information about those patients who are most likely to respond positively to OPDIVO

Synonyms

Nivolumab; Programmed Death Ligand 1

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.
  3. FDA News Release. October 9, 2015. Accessed on FDA website 2/18/16.
  4. Agilent website, PD-L1 IHC 28-8 pharmDx for Autostainer Link 48, accessed 11/7/17.
  5. Opdivo package insert.  BMS website accessed 11/7/17. https://packageinserts.bms.com/pi/pi_opdivo.pdf

CPT Codes

The CPT codes included in this publication are in accordance with Current Procedural Terminology, a publication of the American Medical Association. CPT codes are provided here for the convenience of our clients; however, correct coding often varies from one carrier to another, and LabCorp may bill specific carriers using codes other than those shown. Clients who bill for services should verify the code(s) with the applicable payor to confirm that their use is appropriate in each case.

Profile Policy

LabCorp's policy is to provide physicians, in each instance, with the flexibility to choose appropriate tests to assure that the convenience of ordering test combinations/profiles does not prevent physicians who wish to order a test combination/profile from making deliberate informed decisions regarding which tests are medically necessary. All the tests offered in test combinations/profiles may be ordered individually using the LabCorp test request form.

Please remember that (1) when ordering tests for which Medicare or Medicaid reimbursement is sought, the physician should only order those tests that the physician believes are medically necessary for each patient, (2) that using a customized profile may result in ordering tests for which Medicare or Medicaid will deny payment, (3) that the physician should only order individual tests or a less inclusive profile where not all the tests in the customized test combination/profile are medically necessary for an individual patient, and (4) that the United States Department of Health and Human Services, Office of Inspector General, takes the position that a physician who orders medically unnecessary tests may be subject to civil penalties.

LabCorp encourages clients to contact their local LabCorp representative or LabCorp location if the testing configurations shown here do not meet individual needs for any reason, or if some other combination of procedures is desired.

Investigational Procedures

Some of the individual tests and profile test components listed in this Directory may be considered by Medicare or other insurance carriers as investigational procedures, and therefore, the test may not be payable by the carrier as a covered benefit for the patient. Medicare patients must be informed of this possibility when the physician orders tests that may fall into this category. Affected patients must be asked to sign an Advance Beneficiary Notice, agreeing to be financially responsible if the service is denied by the carrier. Additionally, for other insurance plans, physicians should inform the patient that the service(s) may not be covered by their private insurance plan and, if so, they will be financially responsible for payment. If the patient declines to accept financial responsibility, please do not order the test(s).

As with all clinical assays, results of these tests should be used only in conjunction with other medically established diagnostic elements (eg, symptoms, history, clinical impressions, results from other tests, etc). Physicians should use all the information available to them to diagnose and determine appropriate treatment for their patients. In order to obtain a current list of the procedures that may be considered investigational by Medicare or other insurance carriers, please contact your local LabCorp representative.