On April 24, 2022, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approval for capmatinib (Tabrecta) as a monotherapy for adult patients with advanced non-small cell lung cancer (NSCLC). These patients have a METex14 skipping alteration and require systemic therapy following prior immunotherapy and/or platinum-based chemotherapy.
The recommended approval is based on results from the phase 2 GEOMETRY mono-1 trial (NCT02414139), in which the drug caused an overall response rate (ORR) of 51.6% in a subset of patients (n=31) receiving capmatinib as second-line therapy; this included a partial response (PR) rate of 51.6% and a stable disease rate of 35.5%. The median duration of response (DOR) was 8.4 months, and the disease control rate (DCR) in this subset was 90.3%. The median progression-free survival (PFS) was 6.9 months.
In all previously treated patients (n=100), the objective response rate (ORR) of capmatinib was 44.0%, with a partial response (PR) rate of 44.0% and a stable disease rate of 36.0%. In this population, the median disease-free survival (DOR) with capmatinib was 9.7 months, and the disease control rate (DCR) was 82.0% (95% CI, 73.1%–89.0%). The median disease-free survival in these patients was 5.5 months.
The most common treatment-related adverse events included peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.
These results reveal the therapeutic potential of Tabrecta in patients with MET exon 14 skipping mutations in NSCLC. The superior ORR data in the treatment-naïve group compared to the previously treated group highlight the clinical relevance of early diagnostic detection and early treatment in this challenging patient population.
It's worth noting that Tabrecta is an oral, potent, selective MET inhibitor, and the only FDA-approved therapy specifically for METex14-mutant metastatic NSCLC, regardless of prior treatment.
METex14-mutant advanced non-small cell lung cancer (NSCLC) is a type of lung cancer with an extremely poor prognosis, and there is currently no definitive treatment for this aggressive disease. In the United States, approximately 4,000-5,000 patients are diagnosed with METex14 metastatic NSCLC each year, and due to the presence of the METex14 mutation, these patients have a very poor prognosis.
