European Commission Approves Capmatinib in NSCLC With MET Exon 14 Skipping Mutation

Based on results from the phase 2 GEOMETRY mono-1 trial, the European Commission has approved capmatinib for patients with non–small cell lung cancer who have MET exon 14 skipping mutations, and a need for systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

The European Commission has approved capmatinib (Tabrecta) for adults with non–small cell lung cancer (NSCLC) who have a MET exon 14 skipping mutation and need for systemic therapy after prior treatment with immunotherapy and/or platinum-based chemotherapy, according to a press release from Novartis.1

Results from the phase 2 GEOMETRY mono-1 trial (NCT02414139) led to the approval, and patients received either capmatinib as either second-line treatment (n = 30) or later (n = 1).Among the 31 patients enrolled, the confirmed response rate (ORR) was 51.6% (95% CI, 33.1%-69.8%), with a rate of 44.0% (95% CI, 34.1%-54.3%) among those who received 1 or more prior lines of therapy.

The most common treatment-related adverse effects observed in 20% or more of the population were peripheral edema, nausea, fatigue, increased blood creatinine, vomiting, dyspnea, decreased appetite, and back pain.

“As the leading cause of cancer-related deaths worldwide, lung cancer can be a devastating diagnosis for patients and their families,” Marie-France Tschudin, president of Innovative Medicines International and chief commercial officer at Novartis, said in the press release. “With this new targeted therapy that treats a specific mutation driving cancer growth, we are delivering a much-needed treatment option and bringing hope to patients with this challenging disease.”

In May 2020, the FDA granted accelerated approval to capmatinib for patients with NSCLC who have a MET exon 14 skipping mutation, which is indicated by a FoundationOne CDx assay.2

References

  1. Novartis received European Commission approval for Tabrecta for the treatment of METex14 skipping advanced non–small cell lung cancer. News Release. Novartis. June 22, 2022. Accessed June 22, 2022. https://bit.ly/3ya8r2V
  2. FDA grants accelerated approval to capmatinib for metastatic non–small cell lung cancer. News Release. FDA. May 6, 2020. Accessed June 22, 2022. https://bit.ly/3xJGde4