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TESTING FOR KRAS G12C

NCCN Guidelines recommend biomarker testing for KRAS, including G12C, for all appropriate patients with advanced or metastatic nonsquamous NSCLC, and can be considered for those with squamous histology.1

NCCN=National Comprehensive Cancer Network; NSCLC=non-small cell lung cancer..

IDENTIFYING AN ACTIONABLE DRIVER MUTATION LIKE KRAS G12C CAN INFORM TREATMENT DECISION-MAKING2,3

3 CHARACTERISTICS TO LOOK FOR IN PATIENTS

Past or current smoker icon

Past or current smoker2

Nonsquamous NSCLC/adenocarcinoma icon

Nonsquamous NSCLC/adenocarcinoma1

Unknown KRAS mutation status icon

Unknown KRAS mutation status

EVALUATING BIOMARKER TESTING RESULTS BEFORE INITIATING TREATMENT MAY IMPROVE PATIENT OUTCOMES4

Based on retrospective analysis of a cohort of patients newly diagnosed with stage IV NSCLC with mutations of EGFR, ALK, ROS1, BRAF, MET, RET, HER2, or NTRK1/2/3 (N=510). Patients with KRAS G12C-mutated NSCLC were not included in this analysis.4

ALK=anaplastic lymphoma kinase; BRAF=B-Raf proto-oncogene; EGFR=epidermal growth factor receptor; HER2=human epidermal growth factor receptor 2; MET=mesenchymal epithelial transition; NTRK1/2/3=neurotrophic tyrosine receptor kinase; RET=rearranged during transfection; ROS1=proto-oncogene C-Ros1, receptor tyrosine kinase.

 

MUTATIONAL ANALYSIS IN COMMUNITY SETTING

Study population icon
52%
Tested for >1 driver mutation prior to 1L therapy5*
45%
Patients with advanced NSCLC tested with NGS6†

*Based on a retrospective study assessing real-world biomarker testing patterns in the community setting in patients with de novo metastatic NSCLC treated with systemic therapy between 2017 and 2019 (N=2257). Of the 2257 patients, 1724 had results available for at least 1 driver mutation or PD-L1 during the study period.5
†Based on retrospective observational chart review study of patients with metastatic NSCLC initiating first-line systemic therapy between 10/01/2019 and 03/31/2020 (N=3474).6

1L=first-line; NGS=next-generation sequencing; PD-L1=programmed death-ligand 1.

IDENTIFY PATIENTS WITH KRAS G12C-MUTATED NSCLC WITH AN FDA-APPROVED TEST, SUCH AS:

Qiagen logo

PCR=polymerase chain reaction.

References:

  1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.5.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed December 7, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  2. Kilgoz HO, Bender G, Scandura JM, Viale A, Taneri B. KRAS and the reality of personalized medicine in non-small cell lung cancer. Mol Med. 2016;22:380-387.
  3. Eisenstein M. New lung-cancer drugs extend survival times. Nature. 2020;587(7834):S10-S12.
  4. Scott JA, Lennerz J, Johnson ML, et al. Compromised outcomes in stage IV non-small-cell lung cancer with actionable mutations initially treated without tyrosine kinase inhibitors: a retrospective analysis of real-world data. JCO Onco Pract. 2023;OP2200611.
  5. Nadler E, Vasudevan A, Wang Y, Ogale S. Real-world patterns of biomarker testing and targeted therapy in de novo metastatic non-small cell lung cancer patients in the US oncology network. Cancer Treat Res Commun. 2022;31:100522.
  6. Robert NJ, Espirito JL, Chen L, et al. Biomarker testing and tissue journey among patients with metastatic non-small cell lung cancer receiving first-line therapy in The US Oncology Network. Lung Cancer. 2022;166:197-204.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Gastrointestinal Adverse Reactions

 

  • KRAZATI can cause severe gastrointestinal adverse reactions

  • Monitor and manage patients using supportive care, including antidiarrheals, antiemetics, or fluid replacement, as indicated. Withhold, reduce the dose, or permanently discontinue KRAZATI based on severity

QTc Interval Prolongation

 

  • KRAZATI can cause QTc interval prolongation, which can increase the risk for ventricular tachyarrhythmias (eg, torsades de pointes) or sudden death

  • Avoid concomitant use of KRAZATI with other products with a known potential to prolong the QTc interval. Avoid use of KRAZATI in patients with congenital long QT syndrome and in patients with concurrent QTc prolongation

  • Monitor ECGs and electrolytes, particularly potassium and magnesium, prior to starting KRAZATI, during concomitant use, and as clinically indicated in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, and in patients who are unable to avoid concomitant medications that are known to prolong the QT interval. Correct electrolyte abnormalities. Withhold, reduce the dose, or permanently discontinue KRAZATI, depending on severity

Hepatotoxicity

 

  • KRAZATI can cause hepatotoxicity, which may lead to drug-induced liver injury and hepatitis

  • Monitor liver laboratory tests (AST, ALT, alkaline phosphatase, and total bilirubin) prior to the start of KRAZATI, and monthly for 3 months or as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Reduce the dose, withhold, or permanently discontinue KRAZATI based on severity

Interstitial Lung Disease/Pneumonitis

 

  • KRAZATI can cause interstitial lung disease (ILD)/pneumonitis, which can be fatal

  • Monitor patients for new or worsening respiratory symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever) during treatment with KRAZATI. Withhold KRAZATI in patients with suspected ILD/pneumonitis and permanently discontinue KRAZATI if no other potential causes of ILD/pneumonitis are identified

ADVERSE REACTIONS

 

  • Serious adverse reactions occurred in 57% of 116 patients who received adagrasib in NSCLC patients. The most common adverse reactions in NSCLC patients (≥20%) were diarrhea, nausea, fatigue, vomiting, musculoskeletal pain, hepatotoxicity, renal impairment, dyspnea, edema, decreased appetite, cough, pneumonia, dizziness, constipation, abdominal pain, and QTc interval prolongation

  • Serious adverse reactions occurred in 30% of 94 patients who received adagrasib in combination with cetuximab. The most common adverse reactions in CRC patients (≥20%) were rash, nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, headache, dry skin, abdominal pain, decreased appetite, edema, anemia, dizziness, cough, constipation, and peripheral neuropathy

DRUG INTERACTIONS

 

  • Strong CYP3A4 Inducers: Avoid concomitant use.

  • Strong CYP3A4 Inhibitors: Avoid concomitant use until adagrasib concentrations have reached steady state (after ~8 days).

  • Sensitive CYP3A4 Substrates: Avoid concomitant use with sensitive CYP3A4 substrates.

  • Sensitive CYP2C9 or CYP2D6 Substrates or P-gp Substrates: Avoid concomitant use with sensitive CYP2C9 or CYP2D6 substrates or P-gp substrates where minimal concentration changes may lead to serious adverse reactions.

  • Drugs That Prolong QT Interval: Avoid concomitant use with KRAZATI.

Please see Drug Interactions Section of the Full Prescribing Information for additional information.

USE IN SPECIFIC POPULATIONS

Females and Males of Reproductive Potential

 
  • Infertility: Based on findings from animal studies, KRAZATI may impair fertility in females and males of reproductive potential

Lactation

 
  • Advise not to breastfeed

Please see Full Prescribing Information.

 

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