FDA Approves FoundationOne Liquid CDx as Companion Diagnostic for Tepotinib in METex14-Skipping NSCLC
Key Insights
The FDA has approved FoundationOne Liquid CDx as a companion diagnostic to identify metastatic non-small cell lung cancer (search) (mNSCLC) patients with _MET_ (search) exon 14 skipping alterations.
This approval expands access to precision medicine, enabling clinicians to identify patients who may benefit from treatment with tepotinib (Tepmetko), a targeted MET inhibitor.
The approval is based on data from the phase 2 VISION trial, which demonstrated improved responses with tepotinib in patients with _MET_ (search) exon 14 skipping NSCLC (search).
The FDA has granted approval to FoundationOne Liquid CDx as a companion diagnostic for tepotinib (Tepmetko) in metastatic non-small cell lung cancer (search) (mNSCLC) patients harboring MET exon 14 skipping alterations. This approval marks a significant step forward in precision medicine, enabling clinicians to identify patients who are likely to benefit from tepotinib, a targeted therapy designed to inhibit MET-driven tumor growth.
Precision Medicine for NSCLC
According to Mia Levy, MD, PhD, chief medical officer at Foundation Medicine, access to high-quality liquid biopsies like FoundationOne Liquid CDx can unlock the power of precision medicine for more patients with NSCLC (search). The test analyzes over 300 cancer-related genes using blood samples, providing a non-invasive alternative to tissue biopsies. This is particularly beneficial for patients with advanced NSCLC, where obtaining tissue samples can be challenging.
Efficacy of Tepotinib in VISION Trial
The FDA's decision is supported by data from the phase 2 VISION trial (NCT02864992), a nonrandomized, multicohort, open-label, multicenter study. The VISION trial evaluated the efficacy and safety of tepotinib in patients with MET ex14-skipping NSCLC (search). Tepotinib received accelerated approval in February 2021, followed by full approval on February 15, 2024, based on the VISION trial results.
In the VISION trial, patients received tepotinib at a dose of 500 mg (450 mg active moiety) once daily. The primary endpoint was overall response rate (ORR) as assessed by an independent review committee. Secondary endpoints included duration of response (DOR), progression-free survival, overall survival, and safety.
Clinical Outcomes
Data from cohort C of the VISION study showed an ORR of 57% (95% CI, 49%-65%) among 164 treatment-naive patients, with 40% of responders having a DOR of 12 months or longer. In previously treated patients, the ORR was 45% (95% CI, 37%-53%), and 36% of responders had a DOR of at least 12 months.
The most common adverse events (≥20%) included edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash.
The recommended dose of tepotinib is 450 mg orally once daily with food.
Impact on Patient Care
Laurie Ambrose, president and chief executive officer of GO2 for Lung Cancer, emphasized the importance of biomarker testing in delivering targeted therapies to lung cancer patients. The availability of non-invasive liquid biopsies expands access to treatment options for patients with advanced NSCLC (search).