Sutetinib (irreversible EGFR-TKI) drives 70.8% ORR and 13.7-mo PFS in 1L uncommon EGFR-mutant NSCLC

Sutetinib is an oral irreversible EGFR tyrosine kinase inhibitor (TKI) evaluated in a multicenter, open-label, single-arm Phase IIb trial in locally advanced/metastatic NSCLC with uncommon EGFR mutations (G719X, S768I, L861Q, or predefined compound mutations) with no prior EGFR-TKI exposure (NCT05168566). Among 99 treated patients (96 efficacy-evaluable), IRC-confirmed ORR was 70.8% with DCR 90.6%, median DoR 12.0 months, and median PFS 13.7 months; OS was not reached at median 16.6-month follow-up (data cutoff October 2024). Grade ≥3 TRAEs occurred in 42.4%—notably diarrhea 28.3%—with dose reductions in 34.3% and discontinuations in 4.0%; efficacy looks broadly in-family with current guideline-preferred TKIs for these mutations (afatinib and often osimertinib), where published first-line outcomes typically land around ~55–78% ORR and ~9–14+ month median PFS depending on mutation mix and dataset.