Early Study Findings With Novel KRAS Inhibitor in Advanced Lung Cancers
Posted: Friday, November 22, 2019
New research from a phase I clinical trial testing the safety and toxicity of the novel KRAS inhibitor AMG 510 in patients with the KRAS G12C mutation has shown it to be well tolerated with antitumor activity when administered as monotherapy. The study, conducted by Ramaswamy Govindan, MD, of the Washington University School of Medicine in St. Louis, and colleagues, was presented at the International Association for the Study of Lung Cancer (IASLC) 2019 World Conference on Lung Cancer (WCLC) in Barcelona (Abstract OA02.02).
A total of 76 patients with locally advanced or metastatic malignancies who had received previous standard therapy were included in the trial. Among the follow-up on this larger group was a subset of 34 patients with non–small cell lung cancer (NSCLC). The four dosing groups under study were 180 mg, 360 mg, 720 mg, and 960 mg. Dosing was once daily orally for 21 days, followed by radiographs and examinations. Of the 13 patients receiving 960 mg, 7 achieved a partial response and 6 achieved stable disease.
Of the 34-patient subset, there were no dose-limiting toxicities, and 27 patients remain on treatment. Treatment adverse events of grade 1 or 2 were reported in nine patients. Grade 3 adverse events were reported in three patients.
“KRAS G12C–mutant lung adenocarcinoma is one of the largest subsets of NSCLC potentially amenable to target therapies. I am pleased that we have a promising new oral therapy for this group of patients. The data continue to show encouraging antitumor activity with AMG 510, underscoring the potential to close the treatment gap for [patients with] previously treated KRAS G12C–mutated NSCLC,” shared Dr Govindan in an IASLC press release.
Disclosure: The study authors’ disclosure information may be found at wclc2019.iaslc.org.