FP09.01 Mobocertinib in Platinum-Pretreated EGFR Exon 20 Insertion+ Metastatic NSCLC Patients With/Without Prior Anti-PD(L)-1 Therapy

No approved, targeted therapies are available to specifically treat EGFR exon 20 insertion+ (ex20ins+) non–small cell lung cancer (NSCLC). Anti-programmed-death (ligand)-1 (anti-PD(L)-1) therapies are recommended for NSCLC patients without activating mutations as preferred therapy; however, their efficacy in EGFR ex20ins+ NSCLC is limited, with median progression-free survival (PFS) typically of 2–3 months. Mobocertinib (TAK-788) is an oral EGFR tyrosine kinase inhibitor (TKI) targeting EGFR ex20ins; it holds Breakthrough Therapy Designation for patients with EGFR ex20ins+ NSCLC who previously progressed on platinum-based chemotherapy (in the United States) or who had prior chemotherapy (in China), based on preliminary phase 1/2 results.