伴隨式診斷肺癌標靶用藥

Guardant 360 CDx 在非小細胞肺癌通過多項 FDA 核准藥物。

癌別	生物標記	治療藥物
非小細胞肺癌 (NSCLC)	EGFR exon 19 deletions, L858R, and T790M	泰格沙TAGRISSO® (osimertinib)
	EGFR exon 20 insertions	肺倍恩RYBREVANT® (amivantamab-vmjw)
	ERBB2/HER2 activating mutations (SNVs and exon 20 insertions)	優赫得ENHERTU® (fam-trastuzumab deruxtecan-nxki)
	KRAS G12C	落滿舒LUMAKRAS™ (sotorasib)

Guardant 360 CDx indications

• Osimertinib:
  • FLAURA: Osimertinib in Untreated EGFR-Mutated Advanced Non–Small-Cell Lung Cancer | New England Journal of Medicine
  • AURA3: Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer | New England Journal of Medicine
  • Clinical validation: Pan-Tumor Analytical Validation and Osimertinib Clinical Validation in EGFR Mutant Non–Small-Cell Lung Cancer, Supporting the First Next-Generation Sequencing Liquid Biopsy in Vitro Diagnostic - The Journal of Molecular Diagnostics
• Amivantamab:
  • CHRYSALIS: Clinical Validation of Companion Diagnostics for the Selection of Patients with Non–Small Cell Lung Cancer Tumors Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutations for Treatment with Amivantamab - The Journal of Molecular Diagnostics
• Transtuzumab deruxtecan:
  • DESTINY Lung01/02: Analytical and Clinical Validation of the Plasma-Based Guardant360 CDx Test for Assessing HER2 (ERBB2) Mutation Status in Patients with Non–Small-Cell Lung Cancer for Treatment with Trastuzumab Deruxtecan in DESTINY-Lung01/02 - ScienceDirect
• Sotorasib:
  • CodeBreaK100: Clinical validation of Guardant360 CDx as a blood-based companion diagnostic for sotorasib - Lung Cancer

Guardant 360 肺癌 clinical trials

• NILE (G360 vs SOC; concordance): Clinical Utility of Comprehensive Cell-free DNA Analysis to Identify Genomic Biomarkers in Patients with Newly Diagnosed Metastatic Non–small Cell Lung Cancer | Clinical Cancer Research | American Association for Cancer Research
• SLLIP (G360 vs SOC; concordance): Biomarker Discovery and Outcomes for Comprehensive Cell-Free Circulating Tumor DNA Versus Standard-of-Care Tissue Testing in Advanced Non–Small-Cell Lung Cancer | JCO Precision Oncology
• UK study (G360 vs NGS; concordance): Up-front cell-free DNA next generation sequencing improves target identification in UK first line advanced non-small cell lung cancer (NSCLC) patients - ScienceDirect
• PENN2 (G360 outcomes): Clinical Implications of Plasma-Based Genotyping With the Delivery of Personalized Therapy in Metastatic Non–Small Cell Lung Cancer | Lung Cancer | JAMA Oncology | JAMA Network
• VISION (MET ex14 skipping): Tepotinib in Non–Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations | New England Journal of Medicine