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FDA Approves First Targeted Therapy for Metastatic NSCLC and MET Exon 14 Skipping

December 15, 2020 | Web Exclusives | Lung Cancer

Capmatinib is the first medication approved by the FDA for the treatment of adult patients with metastatic NSCLC that is associated with mutations that lead to mesenchymal-epithelial transition (MET) exon 14 skipping, as determined by an FDA-approved test. The FDA granted capmatinib breakthrough therapy and orphan drug designations.

The FDA also approved Foundation Medicine’s FoundationOne CDx assay (F1CDx) as a companion diagnostic to capmatinib. F1CDx is a next-generation sequencing–based in vitro diagnostic device that can detect a range of mutations, including mutations that lead to MET exon 14 skipping.

“Lung cancer is increasingly being divided into multiple subsets of molecularly defined populations, with drugs being developed to target these specific groups,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence. “Tabrecta is the first approval specifically for the treatment of patients with non–small-cell lung cancer whose tumors have mutations that lead to MET exon 14 skipping. This patient population now has an option for a targeted therapy, which they didn’t have prior to today,” he said.

“In the face of the COVID-19 pandemic, our regular work on reviewing treatments for patients with cancer is moving forward. The impact may be hardest on those with acute or chronic medical conditions and those with weakened immune systems, such as that caused by cancer and some forms of cancer treatment,” Dr Pazdur added.

NSCLC is the most common type of lung cancer and has a high risk for metastasis, often involving MET exon 14 skipping. Approximately 3% to 4% of patients with NSCLC have mutations leading to MET exon 14 skipping.

The FDA based its approval of capmatinib on the results of a clinical trial that enrolled patients with NSCLC and mutations leading to MET exon 14 skipping. All patients in the trial had negative status for EGFR and ALK gene mutations. Participants received oral capmatinib 400 mg twice daily until disease progression or unacceptable toxicity. The trial’s primary efficacy end point was overall response rate (ORR), with a secondary end point of duration of response.

In all, 28 patients were treatment-naïve for NSCLC, whereas 69 patients had received previous therapy. The 28 previously untreated patients had an ORR of 68% (4% complete responses, 64% partial responses). The ORR (all partial responses) for the 69 patients who had received previous therapy was 41%. Of the patients who had a response to capmatinib therapy, 47% of treatment-naïve patients and 32.1% of those who had previously received therapy for NSCLC had a response lasting ≥12 months.

The side effects most commonly associated with capmatinib treatment were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite. Serious side effects included interstitial lung disease or pneumonitis. Patients who experience these serious side effects are advised to discontinue capmatinib therapy permanently. Capmatinib may also cause hepatotoxicity, which would require dose reduction or permanent treatment discontinuation.

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