SUMMARY  

• RYBREVANT (amivantamab-vmjw) is a low fucose, fully-human immunoglobulin G1 (IgG1)-based bispecific antibody with immune cell-directing activity that targets epidermal growth factor receptor (EGFR) mutations and mesenchymal-epithelial transition (MET) mutations and amplifications in non-small cell lung cancer (NSCLC).¹
• RYBREVANT is indicated²:
  • in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion (Exon20ins) mutations, as detected by a United States Food and Drug Administration (FDA)-approved test.
  • as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR Exon20ins mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
• Select patients for treatment with RYBREVANT based on the presence of EGFR Exon20ins mutations in tumor or plasma specimens. If no mutation is detected in a plasma specimen, test tumor tissue. Information on FDAapproved tests is available at: http://www.fda.gov/CompanionDiagnostics.²
• In the ongoing phase 1 CHRYSALIS (NCT02609776) study, EGFR Exon20ins mutation status for the efficacy population (n=81) was determined by prospective local testing using tissue (94%) and/or plasma (6%) samples.
  • Of the 81 patients with EGFR Exon20ins mutations identified by local testing, plasma samples from 78/81 (96%) patients were tested retrospectively using Guardant360^® Companion Diagnostic (CDx), identifying 62/78 (79%) samples with an EGFR Exon20ins mutation; 16/78 (21%) samples did not have an EGFR Exon20ins mutation identified.²
• A bridging study was conducted to clinically validate 2 next generation sequencing (NGS)-based CDx, Guardant360^® CDx and Oncomine™ Dx Target Test (ODxT Test), for detecting EGFR Exon20ins variants.³
  • Results demonstrated a high degree of agreement between results from clinical trial assays (CTAs) for patients enrolled in CHRYSALIS with EGFR Exon20ins mutations, and Guardant360 CDx and ODxT Test.³
  • A high degree of concordance was demonstrated between Guardant360 CDx and ODxT Test.³
  • Comparable overall response rates (ORRs) were observed in CHRYSALIS, Guardant360 CDx, and ODxT Test populations.³
• As described below, the FDA-approved plasma test commercially available from Guardant is intended to be used as a CDx to identify patients with NSCLC who may benefit from treatment with the targeted therapy, such as RYBREVANT, in accordance with the approved product labeling.⁴
• Please refer to the RYBREVANT Prescribing Information and Guardant360^® CDx Physician’s Insert for more information.

Guardant360^® companion diagnostic

Janssen is not the owner or manufacturer of the CDx but has the permission to share the following information provided by Guardant.

Guardant360 CDx is a qualitative next generation sequencing (NGS)-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for detection of single nucleotide variants (SNVs), insertions and deletions (indels) in 55 genes, copy number amplifications (CNAs) in two (2) genes, and fusions in four (4) genes. Guardant360 CDx utilizes circulating cell-free DNA (cfDNA) from plasma of peripheral whole blood collected in Streck Cell-Free DNA Blood Collection Tubes (BCTs). The test is intended to be used as a companion diagnostic to identify patients with NSCLC who may benefit from treatment with targeted therapies, such as RYBREVANT, in accordance with the approved therapeutic product labeling.⁴

The test is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for cancer patients with any solid malignant neoplasm. The test is for use with patients previously diagnosed with cancer and in conjunction with other laboratory and clinical findings.⁴

• Guardant360 CDx is a single-site assay performed at Guardant Health, Inc.
• For additional information regarding the Guardant360 CDx, please consider the following options:
  • Visit the Guardant360 CDx website at: https://guardant360cdx.com.
  • Contact Guardant Health Client Services at:
    • Tel: 855.698.8887
    • Fax: 888.974.4258
    • Email: [email protected]

Additional Information

For information regarding other commercially available NGS tests or laboratory developed tests, please speak with the pathologist at your institution or contact the manufacturer of the test.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 11 June 2024.