1520 - PD-L1 (Programmed Death 1 Ligand) immunohistochemistry testing for access to pembrolizumab as second/third-line treatment of patients with recurrent or metastatic, unresectable (advanced) adenocarcinoma of the stomach or GEJ (gastro-oesophageal junction)

Page last updated: 20 February 2018

Application Detail



Description of Medical Service

It is proposed that immunohistochemistry (IHC) test be used for the evaluation of Programmed Cell Death- Ligand 1 (PD-L1) expression to determine eligibility for treatment with pembrolizumab in patients diagnosed with advanced gastric or GEJ cancers that have progressed following a first or second line treatment. Tissue obtained at diagnosis will be used for immunohistochemical testing of PD-L1 expression. For patients who did not have testing undertaken at diagnosis or have archival tissue samples available, newly obtained tissue will be used. The testing would be done by a pathologist, and it is proposed that the test is a pathologist determinable test. In the pivotal phase III trial (KN-061), PD-L1 testing was performed on newly obtained tissue. However, archival tissue samples are also being assessed for each patient (where available) to support evaluation of the clinical utility of PD-L1 assessment based on newly obtained vs. archived tissue samples.

Description of Medical Condition

Patients included within this application will have recurrent, unresectable or metastatic adenocarcinoma of the stomach or GEJ that has progressed during or following a first-line or second-line therapy and are PD-L1 positive (as determined by Combined Positive Score, or CPS).

Reason for Application

New MBS item

Medical Service Type

Co-dependent technology

Previous Application Number

Not Applicable

Associated Documentation

Application Form


Consultation Survey


PICO Confirmation


Assessment Report


Public Summary Document


Meetings for this Application