FDA OKs FoundationOne Liquid CDx for Tepotinib in METex14-Skipping NSCLC
The FDA has approved FoundationOne Liquid CDx as a companion diagnostic for patients with metastatic non–small cell lung cancer with MET exon 14 skipping alterations eligible for tepotinib.
- The FDA has granted approval to the FoundationOne Liquid CDx for a new indication.
- The laboratory test is now approved as a companion diagnostic to identify patients with metastatic non–small cell lung cancer (mNSCLC) harboring MET exon 14 skipping alterations who may be eligible for treatment with tepotinib (Tepmetko).
- This marks the first FDA-approved companion diagnostic for the identification of patients who may benefit from tepotinib.
The FDA has approved FoundationOne Liquid CDx as a companion diagnostic to identify patients with metastatic NSCLC harboring MET exon 14 skipping alterations.1 This approval will help clinicians identify patients who may benefit from treatment with tepotinib (Tepmetko), a targeted therapy designed to inhibit MET-driven tumor growth.
“Access to a high-quality liquid biopsy, like FoundationOne Liquid CDx, can help unlock the power of precision medicine for more patients with NSCLC,” said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine, in a press release. “We’re proud that our liquid biopsy is the first companion diagnostic approved in the United States for [tepotinib] as it will help identify more patients with MET exon 14 skipping alterations who may be appropriate for targeted treatment.”
The FoundationOne companion diagnostics can analyze over 300 cancer-related genes using either blood or tissue samples.
In February 2021, the FDA granted tepotinib accelerated approval for the treatment of adult patients with mNSCLC harboring MET exon 14 skipping alterations. This was followed by the regular approval of tepotinib from the FDA on February 15, 2024, in this patient population.2 Data from the phase 2 VISION trial (NCT02864992) served as the basis for both approvals as tepotinib demonstrated improved responses.3
Microscopic, photorealistic image of lung cancer cells - Generated with Adobe Firefly
The nonrandomized, multicohort, open-label, multicenter VISION study enrolled patients with METex14-skipping NSCLC. Patients were treated with tepotinib at a dose of 500 mg (450 mg active moiety) once a day. Investigators assessed the primary end point of overall response rate (ORR) by an independent review committee, and secondary end points of duration of response (DOR), progression-free survival, overall survival, and safety.
According to findings from cohort C of the study, the ORR among 164 treatment-naive patients was 57% (95% CI, 49%-65%), with 40% of responders having a DOR of 12 months or longer. The ORR was 45% (95% CI, 37%-53%) in patients who had previously received treatment, and in this cohort of patients, 36% of responders had a DOR of at least 12 months.
For safety, the most frequent adverse events seen in 20% of patients or more included edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash.2
With the approval, the recommended dose of tepotinib was set at 450 mg orally once daily with food.
“Targeted therapies have led a revolution to how lung cancer is treated,” added Laurie Ambrose, president and chief executive officer of GO2 for Lung Cancer, in the press release.1 “Biomarker testing plays a crucial part in getting these treatments into the hands of patients. We’re excited to see that patients with advanced NSCLC have more access to treatment options because of noninvasive liquid biopsies.”
REFERENCES
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. Foundation Medicine. November 18, 2024. Accessed November 18, 2024. https://tinyurl.com/38wxbvpj
FDA approves tepotinib for metastatic non-small cell lung cancer. FDA. February 15, 2024. Accessed November 18, 2024. https://tinyurl.com/nybwyr4j
Paik PK, Garassino MC, Le X, et al. Long-term outcomes of tepotinib in patients with MET exon 14 skipping NSCLC from the VISION study. J Clin Oncol. 2023;41(suppl 16):9060. doi:10.1200/JCO.2023.41.16_suppl.9060
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