China-based partners SZYY Group Pharmaceutical and Medolution announced the initiation of a Phase III trial for sutetinib, an EGFR inhibitor targeting non-classical mutations (G719X/S768I/L861Q) in untreated advanced non-small cell lung cancer (NSCLC). The randomised open-label study (n=219) will compare sutetinib (80 mg daily) versus platinum-doublet chemotherapy, with progression-free survival (PFS) as the primary endpoint. Phase II data presented in 2023 showed an objective response rate (ORR) of 92.9% in the 80 mg cohort (13/14 patients), with median duration of response (DOR) reaching 20.3 months.

Safety analysis revealed grade ≥3 adverse events (AEs) in 80% of high-dose patients, primarily diarrhoea (36.7%) and liver dysfunction (13.3%). SZYY holds exclusive rights to sutetinib in China under a 2021 agreement with Medolution, which retains overseas commercialisation rights. The drug's efficacy in rare EGFR variants addresses an unmet need, as these mutations lack approved targeted therapies globally.