Single-Agent Divarasib in Patients With KRAS G12C–Positive Non–Small Cell Lung Cancer: Long-Term Follow-Up of a Phase I Study

AG Sacher; WH Miller; MR Patel; L Paz-Ares; A Santoro; MJ Ahn; R Dziadziuszko; P Freres; J Luo; S Bowyer; J Desai; B Markman; M De Miguel; S Deva; A Falcon; G Alonso; J Daniel Guedes; SH Kim; MG Krebs; SA Laurie; E Massarelli; L Medina; H Prenen; A Amatu; M Van Dongen; Y Choi; X Hou; T Qi; MT Lin; K Koli; MC Mayo; KK Yau; S Royer-Joo; J Chang; T Jun; NV Dharia; JL Schutzman; P Lorusso

Journal article

Single-Agent Divarasib in Patients With KRAS G12C–Positive Non–Small Cell Lung Cancer: Long-Term Follow-Up of a Phase I Study

AG Sacher, WH Miller, MR Patel, L Paz-Ares, A Santoro, MJ Ahn, R Dziadziuszko, P Freres, J Luo, S Bowyer, J Desai, B Markman, M De Miguel, S Deva, A Falcon, G Alonso, J Daniel Guedes, SH Kim, MG Krebs, SA Laurie Show all

Journal of Clinical Oncology | Published : 2025

DOI: 10.1200/JCO-25-00040

Open access

Abstract

Divarasib (GDC-6036), an oral, highly potent and selective next-generation KRAS G12C inhibitor, has demonstrated a manageable safety profile and promising antitumor activity in patients with advanced KRAS G12C–positive non–small cell lung cancer (NSCLC). Here, we report long-term (≥1 year) follow-up of single-agent divarasib from the ongoing, open-label, and multicenter phase I study (ClinicalTrials.gov identifier: NCT04449874). The primary objective was safety, and the other objectives included preliminary antitumor activity. Overall, 65 patients with advanced KRAS G12C–positive NSCLC received single-agent oral divarasib 50-400 mg once daily and 31 patients (48%) were treated beyond 1 year...

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