FoundationOne Liquid CDx Approved as Companion Diagnostic for Capmatinib Use in METex14+ NSCLC

Foundation Medicine announced the expanded indication for FoundationOne Liquid CDx as a companion diagnostic to identify MET exon 14 skipping mutations in metastatic non–small cell lung cancer.

The FDA granted approval to FoundationOne Liquid CDx as a companion diagnostic to help identify patients with MET exon 14 skipping mutations (METex14) in metastatic non­–small cell lung cancer (NSCLC) for whom capmatinib (Tabrecta) would be an appropriate treatment option, according to a press release from the company responsible for the agent, Foundation Medicine, Inc.

For adult patients with metastatic NSCLC whose tumors harbor METex14, capmatinib is the first FDA-approved therapy approved specifically to target this aberration.

“For lung cancer patients with METex14, having the option of a non-invasive liquid biopsy expands access to this first-of-its kind therapy and helps meet a critical patient need,” Brian Alexander, MD, MPH, chief executive officer at Foundation Medicine, said in a press release. “This approval, coupled with last year’s simultaneous therapy and companion diagnostic approval for Tabrecta and our tissue test, FoundationOne CDx, is an important advancement and demonstrates the value of having multiple highly-validated comprehensive genomic testing options for physicians to consider for the individual needs of each patient.”

FoundationOne Liquid CDx uses a blood sample to analyze over 300 cancer-related genes in search of genomic alterations. Capmatinib is just the second therapy to have both FoundationOne CDx and FoundationOne Liquid CDx approved as companion diagnostics.

With this approval, the FoundationOne Liquid CDx test is now approved as a companion diagnostic for 9 different targeted therapeutic strategies in 4 tumor types.

The FDA previously granted accelerated approval to capmatinib in May of 2020 for adult patients with metastatic NSCLC whose tumors have a mutation that leads to METex14 as detected by an FDA-approved test. At the same time, FoundationOne CDx, an assay that tests for genetic alterations in tumor tissue, was also granted approval as a companion diagnostic for capmatinib.

Capmatinib’s approval was informed by data from the multicohort phase 2 GEOMETRY mono-1 trial (NCT02414139), which evaluated 97 patients with metastatic NSCLC and confirmed METex14.

Patients were given twice daily oral capmatinib at 400 mg until disease progression or unacceptable toxicity.

The primary end point was overall response rate (ORR) determined by a blinded independent review committee by RECIST 1.1. Secondary end points were duration of response (DOR), time to response, disease control rate, progression-free survival, and overall survival.

In treatment-naïve patients (n = 28), the ORR was 68% (95% CI, 48%-84%) and the DOR was 12.6 months (95% CI, 5.5-25.3). Out of the 69 previously treated patients, the ORR was 41% (95% CI, 29%-53%) and the DOR of 9.7 months (95% CI, 5.5-13.0).

The most common adverse events were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite. Further, capmatinib has also been known to cause interstitial lung disease, hepatotoxicity, photosensitivity, and embryo-fetal toxicity.

Reference

Foundation Medicine Expands Indication for FoundationOne®Liquid CDx to be Used as a Companion Diagnostic for TABRECTA® (capmatinib). News release. Foundation Medicine. Published July 15, 2021. Accessed July 16, 2021. https://bit.ly/2VEMsAr