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Abstract
Background. Capmatinib has demonstrated high anti-tumor activity, as well as a manageable safety profile, in patients with advanced NSCLC with MET exon 14 (METex14) mutation in the Phase II Geometry mono-1 study.
Aim. Estimation of the efficacy and safety of capmatinib in the Russian subgroup of patients in the Geometry mono-1 study.
Materials and methods. Patients were enrolled in the Geometry mono-1 study according to their MET status and line of therapy. The Russian subgroup included patients treated with capmatinib as first- and second-line therapy. Capmatinib was administered at a dosage of 400 mg twice daily. The primary endpoint was objective response rate (ORR), and clinical benefit rate (CBR). The secondary endpoints were duration of response, progression-free survival (PFS), overall survival (OS) and safety profile.
Results. The analysis included 13 patients (4 males and 9 females) aged 59 to 82 years with metastatic NSCLC with METex14 mutation. ORR was 50% and CBR was 100% in the patients treated with capmatinib in the 1st line (n=6). ORR was 14.3%, and CBR was 71.4 in the 2nd line of the therapy (n=7). The median duration of response, regardless of therapy line, was 5.7 months. The median PFS with administration of capmatinib in the 1st line was 21.3 months, and in the 2nd line ― 3.5 months.
The median OS, depending on the line of the therapy, was as follows: in the 1st line ― 21.3 months, and in the 2nd ― 24.6 months.
The most common treatment-related adverse events (AEs) were peripheral edema (69.2%), hypocalcemia (53.8%), increased creatinine (46.2%); most of them were grade 1/2. No unexpected AEs were registered.
Conclusion. A high response to capmatinib treatment was registered in the Russian population. The therapy was well tolerated.
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