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Amgen Announces New Clinical Data Evaluating Novel Investigational KRAS(G12C) Inhibitor In Larger Patient Group At WCLC 2019
THOUSAND OAKS, Calif., Sept. 8, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data from the ongoing Phase 1 study evaluating AMG 510 in
About this update from Amgen Inc.
[{"type":"text","content":"THOUSAND OAKS, Calif., Sept. 8, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data from the ongoing Phase 1 study evaluating AMG 510 in patients with previously treated KRAS G12C-mutated solid tumors. AMG 510 is a first-in-class investigational oral therapy that is designed to selectively and irreversibly target the KRASG12C protein. The additional follow-up in a larger group of patients with non-small cell lung cancer (NSCLC) continued to show anti-tumor activity with no dose-limiting toxicities. These data are being presented during an oral presentation at IASLC 2019 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer.\nInitial data from the Phase 1 study were presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) earlier this year. The additional follow-up in a larger group of patients being presented at WCLC includes a subset of 34 NSCLC patients enrolled, with 23 of the patients being evaluable for efficacy. Thirteen of the evaluable patients received the target dose of 960 mg once daily, of which seven (54%) achieved a partial response at one or more timepoints and six (46%) achieved stable disease, for a disease control rate of 100%. \n\"These new data reinforce the earlier positive response rate we shared at ASCO in more non-small cell lung cancer patients receiving AMG 510,\" said David M. Reese, M.D., executive vice president of Research and Development at Amgen. \"We remain enthusiastic about the promise of AMG 510 and continue to rapidly advance its development program both as monotherapy and in combination.\"\nAmong the 34 NSCLC patients enrolled, there were no observed dose-limiting toxicities and no adverse events leading to discontinuation. Twenty-seven of these patients remain on treatment. Of the 34 patients, only nine (26.5%) reported treatment-related adverse events (TRAEs) of grade 1 or 2. Three patients reported grade 3 TRAEs (anemia and diarrhea). There were no grade 4 or higher TRAEs. \n\"There is a need for targeted treatments for specific driver mutations of cancer that do not have an approved therapy,\" said Ramaswamy Govindan, M.D., principal investigator and professor at Washington University School of Medicine in St. Louis. \"These data continue to show encouraging anti-tumor activity with AMG 51...