FDA Approves FoundationOne Liquid CDx as Diagnostic Tool for NSCLC

FoundationOne Liquid CDx has been approved as a diagnostic tool for tepotinib in patients with non–small cell lung cancer METex14 skipping alterations.

The FDA issued approval for FoundationOne®Liquid CDx to be used as a companion diagnostic with tepotinib (Tepmetko) for patients with metastatic non–small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations, according to the developer, Foundation Medicine, Inc.¹

FoundationOne®Liquid CDx is a qualitative next-generation sequencing in vitro diagnostic test. It finds and reports genomic alterations more than 300 cancer-related genes through targeted high-throughput hybridization-based capture technology.

Mia Levy, MD, PhD, chief medical officer at Foundation Medicine said, “Access to a high-quality liquid biopsy, like FoundationOne LiquidCDx, can help unlock the power of precision medicine for more patients with non–small cell lung cancer. We’re proud that our liquid biopsy is the first companion diagnostic approved in the US for [tepotinib] as it will help identify more patients with MET exon 14skipping alterations who may be appropriate for targeted treatment.”²

Tepotinib was previously granted accelerated approval for this indication in February 2021. It was then granted traditional approval for patients with NSCLC in February 2024 by the FDA with supporting results coming from the phase 2, multicohort, open-label, multicenter VISION study (NCT02864992).

Overall, patients received tepotinib for a mean of 11.5 months (SD, 11.6), with a median follow-up time of 32.6 months.³ The overall response rate (ORR) was 51.4%, the median progression-free survival (mPFS) was 11.2 months, median overall survival (mOS) was 19.6 months, and the median duration of response (mDOR) was 18.0 months.

A total of 313 patients were enrolled with a median age of 72 years. Patients were given tepotinib at 500 mg once daily in 21-day cycles until disease progression, death, and adverse effects (AE) leading to discontinuation, or withdrawal of consent.

The trial was broken into 3 cohorts: cohort A, for patients with MET exon 14skipping alterations; cohort B, for patients with MET-amplification; and cohort C, an independent cohort designed to verify the findings from cohort A.

Patients who received tepotinib as a first-line therapy (n = 164) received treatment for 12.4 months (SD, 12.2), and 27 patients (16.5%) are still receiving treatment. The ORR was 57.3%, mDOR was 46.4 months, mPFS was 12.6 months, and mOS was 21.3 months.

Patients who took tepotinib as a second-line or later therapy (n = 149) received treatment for a mean of 10.5 months (SD, 11.0), and 10 patients (6.7%) are still receiving treatment. The ORR among this group was 45.0%, mPFS was 11.0 months, mOS was 19.3 months, and mDOR was 12.6 months.

In the overall population, 91.7% reported experiencing treatment-related AEs. Furthermore, 15.7% reported serious AEs, 34.8% reported AEs of grade 3 or higher, 3.8% reported AEs of grade 4 or higher, and 33.5% had AEs that led to dose reduction. The most common treatment-related AEs were peripheral edema, nausea, and hypoalbuminemia.

There were 3 patients who had AEs leading to death, 1 of which was due to a progressive disease or lung cancer-related condition that led to multiple organ failure, which was considered treatment-related because of a missing causality report.

References

1. U.S. Food and Drug Administration approves FoundationOne®Liquid CDx as a companion diagnostic for TEPMETKO® (tepotinib) to identify patients with MET exon 14 skipping alterations in non-small cell lung cancer. News Release. Yahoo Finance. November 18, 2025. Accessed November 19, 2024. https://tinyurl.com/36faxf46
2. FDA approves tepotinib for metastatic non-small cell lung cancer. News Release. FDA. February 2, 2024. Accessed November 19, 2024. https://tinyurl.com/2jyx7vfr
3. Long-term outcomes of tepotinib in patients with MET exon 14 skipping NSCLC from the VISION study. American Society of Clinical Oncology Annual Meeting 2024.