China-based Qilu Pharmaceutical has unveiled first-in-human data for QLC1101, a proprietary oral KRAS G12D inhibitor, in a Phase I study of 52 pre-treated non-small cell lung cancer (NSCLC) patients with the G12D mutation (median exposure 58 days). Among 42 response-evaluable subjects, objective response rate (ORR) was 26.2%, disease control rate (DRC) 78.6%, and median progression-free survival (PFS) 7.2 months, with 37.4% of patients progression-free at 9 months.

In the recommended Phase II dose cohort (1,200 mg twice daily, n=31), DCR rose to 90.9%, median PFS was not yet reached, and 67.1% remained progression-free at 9 months, against a mostly grade 1 to 2 adverse event profile led by diarrhoea (65.4%), vomiting (61.5%), and nausea (40.4%); grade 3 or higher treatment-related events occurred in 9.6% with no discontinuations or deaths.