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
- 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
- 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
These data support less restrictive clinical trial eligibility criteria for those with metastatic NSCLC. This is especially true regarding both targeted therapy and immunotherapy treatment regimens.
