Amgen announces new data evaluating novel investigational KRAS inhibitor
Amgen announced new data from the ongoing Phase 1 study evaluating AMG 510 in patients with previously treated KRAS G12C-mutant solid tumors. The data include the first evidence of anti-tumor activity reported in patients with colorectal cancer and appendiceal cancer, as well as previously presented non-small cell lung cancer findings. AMG 510 continues to be well-tolerated with no dose-limiting toxicities. The study enrolled 76 patients with KRAS G12C-mutant solid tumors. Data being presented at ESMO include a subset of 55 evaluable patients as of the July 2019 data cutoff, including CRC, appendiceal cancer and NSCLC patients from the Phase 1 study. Of the 55 patients, 29 had CRC. 12 patients with CRC received the target dose of 960 mg once daily and 10 remain on treatment. One patient in this dose cohort experienced a partial response and 10 had stable disease for a disease control rate of 92%. 13 of the evaluable patients with NSCLC received 960 mg, of which seven achieved a partial response at one or more timepoints and six achieved stable disease, for a disease control rate of 100%. Data across dosing cohorts also showed tumor responses in two evaluable patients with appendiceal cancer with one partial response and one experiencing stable disease. Among the 76 patients enrolled across treatment groups, 52 remain on treatment. The majority of treatment-related adverse events were grade 1 and 2. Only two TRAEs were grade 3. There were no grade 4 or higher TRAEs.