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 A clear vision of the potential clinical response to immunotherapy.

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Investigate beyond PD-L1

The arrival of immune checkpoint (ICP) inhibitors in biopharma’s development pipelines has brought many changes to the oncology clinical trial landscape. Should it be for monotherapy or for combination study, all patients entering an ICP inhibitor clinical trial should be characterized, not only for PD-L1 expression but for as many ICP inhibitor related biomarkers as possible.

Our immunogram is created based on 5 key points, PD-L1 % (FDA) , TMB (ASCO 2017) (12), CD8 T-cell infiltrate (ASCO 2017), MSI(FDA) and Sensitivity/Resistance mutations (ASCO 2017)(13). With those tools, we are able to give you a clear vision of the potential clinical response of your patient.

Mutations associated with sensitivity (e.g. POLE inactivating mutations) or resistance (e.g. STK11 inactivating mutations) to ICP inhibitors. We can test this continuously growing number of variants associated with an impact on immunotherapy.

MSI, a type of genomic instability, is characterised by gains or losses of nucleotides from microsatellite tracts. It results from impaired DNA mismatch repair (MMR) and MSI-H(igh) status has been associated with high response rates and survival benefit for patients treated with checkpoint inhibitors.

TMB is a measurement of the mutations carried by tumor cells (number of mutations by units of coding area) and it correlates with higher level of neoantigens. High TMB has been associated with better response and increased survival rate for patients treated with ICP inhibitors.

The presence of CD8+ lymphocytes has been associated with better clinical outcomes for patients treated with ICP inhibitors.

This is the first FDA approved biomarker. Although several antibodies exist to detect PD-L1 expression, only PD-L1 IHC 22C3 pharmDx (Dako) is approved as a companion diagnostic for pembrolizumab. Dako’s PD-L1 IHC 28-8 pharmDx is approved as a complementary diagnostic for nivolumab. These two antibodies and others are available at OncoDNA.