KRAS G12C and EGFR make up ~ 75% of all actionable driver mutations in NSCLC2
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend testing for KRAS in all eligible patients with advanced NSCLC3,*,†,‡
CAP/IASLC/AMP and ASCO Guidelines recommend testing for actionable biomarkers (eg, KRAS) utilizing either a comprehensive panel or targeted testing4
Consider testing all eligible patients with NSCLC for KRAS G12C at diagnosis
Consider ordering KRAS alongside other actionable biomarkers (eg, EGFR, ALK, ROS1)
*The NCCN Guidelines for NSCLC provide recommendations for individual biomarkers that should be tested and recommend testing techniques, but do not endorse any specific commercially available biomarker assays or commercial laboratories.3
†It is recommended at this time that, when feasible, testing be performed via a broad, panel-based approach, most typically performed by NGS.3
‡Does not include locally advanced.3
ALK, anaplastic lymphoma kinase; AMP, Association for Molecular Pathology; ASCO, American Society of Clinical Oncology; CAP, College of American Pathologists; EGFR, epidermal growth factor receptor; IASLC, International Association for the Study of Lung Cancer; KRAS, Kirsten rat sarcoma viral oncogene homolog; NCCN, National Comprehensive Cancer Network; NGS, next-generation sequencing; NSCLC, non-small cell lung cancer; ROS1, c-ros oncogene 1.
Most NGS panels already include KRAS G12C9
When ordering single-gene biomarker tests, consider adding KRAS G12C
Liquid biopsy has high degrees of concordance with tissue-based testing, with 93% concordance for KRAS mutations in patients with mNSCLC8
For Pathologists: FFPE tissue is gold standard. You can test for KRAS G12C using NGS, PCR, and Sanger sequencing methods8,9
Call your lab and ask about your patient’s KRAS G12C status
§Cost estimates herein are for informational purposes only and may not actually represent what patients ultimately pay for certain tests. Further, it should not be construed as any statement, promise, or guarantee by Amgen concerning coverage and/or levels of reimbursement, payment, or charge. Laws, regulations, and policies concerning reimbursement are complex and are updated frequently.
FFPE, formalin-fixed, paraffin-embedded; mNSCLC, metastatic non-small cell lung cancer; OOP, out of pocket; PCR, polymerase chain reaction.
**Information on FDA-approved tests can be found at https://www.fda.gov/medical-devices/products-and-medical-procedures/vitro-diagnostics.
In other tumor types, KRAS is sometimes reported as mutant or wild-type without specifying the variant13
In NSCLC, specific KRAS mutations should be reported at the variant level14,††
There are differences in how reports may list KRAS G12C14
There are various ways that KRAS G12C mutations can be reported, such as Gly12Cys or 12Cys15
For ease of interpretation, consider noting KRAS G12C in the synopsis of your report
In NSCLC, consider reporting KRAS at the variant level and consider updating your test requisition forms to show KRAS includes the G12C point mutation
††Not comprehensive of all possible variants.
Interstitial Lung Disease (ILD)/Pneumonitis
Most common adverse reactions
LUMAKRAS™ is indicated for the treatment of adult patients with KRAS G12C‑mutated locally advanced or metastatic non‑small cell lung cancer (NSCLC), as determined by an FDA‑approved test, who have received at least one prior systemic therapy.
This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Please see full Prescribing Information.