Table 1.
Predictive biomarkers for treatment selection in Non-Small Cell Lung Cancer.
| Biomarker | Alteration of Interest | Assay | Frequency in NSCLC | FDA-Approved Targeted Therapies for NSCLC * |
|---|---|---|---|---|
| EGFR | Exon 19 deletion L858R point mutation in exon 21 L861Q point mutation in exon 21 G719X in exon 18 Other rarer activating mutations |
PCR based mutation testing | ~15% in Western populations ~35–50% in Asian populations |
Erlotinib Afatinib Gefitinib Necitumumab |
| EGFR | T790M mutation in exon 20 | PCR based mutation testing | 60% in patients with disease progression following EGFR TKI | Osimertinib |
| ALK | ALK rearrangement | IHC ± FISH | 3–7% | Crizotinib Ceritinib Alectinib Brigatinib |
| ROS1 | ROS1 rearrangement | IHC screening and FISH confirmation | 1–2% | Crizotinib |
| BRAF | V600E mutation | PCR based mutation testing | 1–3% | Dabrafenib Trametinib |
| PD-L1 | High protein expression | IHC | ~30% ** | Pembrolizumab |
* status of FDA approval current at the time of this review; ** Approximately 30% of advanced stage NSCLC have high PD-L1 expression (tumor proportion score of at least 50%).