FDA Approves FoundationOne Liquid CDx as Companion Diagnostic for Tepotinib in NSCLC
Key Insights
The FDA has approved FoundationOne Liquid CDx (search) as a companion diagnostic for tepotinib in metastatic non-small cell lung cancer (search) (NSCLC (search)) patients with MET exon 14 skipping alterations.
Tepotinib, a targeted therapy, received traditional approval in February 2024 based on the VISION study, demonstrating an overall response rate of 51.4% and a median overall survival of 19.6 months.
FoundationOne Liquid CDx (search) identifies genomic alterations in over 300 cancer-related genes, aiding in precision medicine for NSCLC (search) patients who may benefit from tepotinib treatment.
The FDA has granted approval for FoundationOne Liquid CDx (search) as a companion diagnostic for tepotinib (Tepmetko) in patients with metastatic non-small cell lung cancer (search) (NSCLC (search)) harboring MET exon 14 skipping alterations. This approval expands the utility of liquid biopsies in identifying patients who may benefit from targeted therapy.
Tepotinib received accelerated approval in February 2021, followed by traditional approval in February 2024 based on data from the phase 2 VISION study (NCT02864992). The multicenter, open-label study demonstrated the efficacy and safety of tepotinib in patients with MET exon 14 skipping NSCLC (search).
VISION Study Results
The VISION study enrolled 313 patients with a median age of 72 years. Patients received tepotinib at 500 mg once daily in 21-day cycles until disease progression, death, unacceptable adverse events, or withdrawal of consent. The primary endpoint was overall response rate (ORR), with secondary endpoints including duration of response (DOR), progression-free survival (PFS), and overall survival (OS).
Key findings from the VISION study include:
- An ORR of 51.4%.
- A median PFS of 11.2 months.
- A median OS of 19.6 months.
- A median DOR of 18.0 months.
In patients who received tepotinib as first-line therapy (n = 164), the ORR was 57.3%, the median DOR was 46.4 months, the median PFS was 12.6 months, and the median OS was 21.3 months. For those who received it as second-line or later therapy (n = 149), the ORR was 45.0%, the median PFS was 11.0 months, the median OS was 19.3 months, and the median DOR was 12.6 months.
FoundationOne Liquid CDx
FoundationOne Liquid CDx (search) is a next-generation sequencing-based in vitro diagnostic test that identifies genomic alterations in over 300 cancer-related genes. This allows for comprehensive genomic profiling from a liquid biopsy sample, providing clinicians with valuable information to guide treatment decisions.
Dr. Mia Levy, chief medical officer at Foundation Medicine, stated that access to high-quality liquid biopsies like FoundationOne Liquid CDx (search) can help unlock the power of precision medicine for more patients with NSCLC (search). She added that Foundation Medicine is proud that their liquid biopsy is the first companion diagnostic approved in the US for tepotinib, as it will help identify more patients with MET exon 14 skipping alterations who may be appropriate for targeted treatment.
Safety Profile
In the VISION study, 91.7% of patients experienced treatment-related adverse events (AEs). Serious AEs were reported in 15.7% of patients, with 34.8% experiencing AEs of grade 3 or higher. The most common treatment-related AEs were peripheral edema, nausea, and hypoalbuminemia. AEs led to dose reduction in 33.5% of patients.
While three patients experienced AEs leading to death, only one was considered treatment-related due to a missing causality report, stemming from a progressive disease or lung cancer-related condition that led to multiple organ failure.