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.

Email us at pmc@pharmcube.com for a free database trial, exclusive reports, or a 1-on-1 consultation