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)

New MBS item.

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.

Type: Co-dependent technology

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).

• PASC meeting: -
• ESC meeting: -
• MSAC meeting: -