Capmatinib

A phase II study (GEOMETRY [NCT02414139]) evaluated capmatinib (400 mg orally twice daily) in patients with MET exon 14-skipping variants or MET amplification. MET status was performed centrally. A total of 373 patients were enrolled and treated. Of those patients, 160 had NSCLC with MET exon 14-skipping variants. Patients were assigned to cohorts based on MET status and previous treatments (cohorts 1a–7). There were 60 treatment-naïve patients (cohorts 5b and 7) and 100 previously treated patients (cohorts 4 and 6). The primary end point was overall response rate.[88][Level of evidence B3] The FDA approved capmatinib for patients with metastatic NSCLC and MET exon 14-skipping variants.

A phase II study (GEOMETRY [NCT02414139]) evaluated capmatinib (400 mg orally twice daily) in patients with MET exon 14-skipping variants or MET amplification. MET status was performed centrally. A total of 373 patients were enrolled and treated. Of those patients, 160 had NSCLC with MET exon 14-skipping variants. Patients were assigned to cohorts based on MET status and previous treatments (cohorts 1a–7). There were 60 treatment-naïve patients (cohorts 5b and 7) and 100 previously treated patients (cohorts 4 and 6). The primary end point was overall response rate.[88][Level of evidence B3] The FDA approved capmatinib for patients with metastatic NSCLC and MET exon 14-skipping variants.

The overall median follow-up was 46.4 months (interquartile range [IQR], 41.8–65.4) for treatment-naïve patients and 66.9 months (IQR, 56.7–73.9) for previously treated patients.

A phase II study (GEOMETRY [NCT02414139]) evaluated capmatinib (400 mg orally twice daily) in patients with MET exon 14-skipping variants or MET amplification. MET status was performed centrally. A total of 373 patients were enrolled and treated. Of those patients, 160 had NSCLC with MET exon 14-skipping variants. Patients were assigned to cohorts based on MET status and previous treatments (cohorts 1a–7). There were 60 treatment-naïve patients (cohorts 5b and 7) and 100 previously treated patients (cohorts 4 and 6). The primary end point was overall response rate.[88][Level of evidence B3] The FDA approved capmatinib for patients with metastatic NSCLC and MET exon 14-skipping variants.

The overall response rate was 68% (95% CI, 55.0%–79.7%) in treatment-naïve patients and 44% (95% CI, 34.1%–54.3%) in previously treated patients.

A phase II study (GEOMETRY [NCT02414139]) evaluated capmatinib (400 mg orally twice daily) in patients with MET exon 14-skipping variants or MET amplification. MET status was performed centrally. A total of 373 patients were enrolled and treated. Of those patients, 160 had NSCLC with MET exon 14-skipping variants. Patients were assigned to cohorts based on MET status and previous treatments (cohorts 1a–7). There were 60 treatment-naïve patients (cohorts 5b and 7) and 100 previously treated patients (cohorts 4 and 6). The primary end point was overall response rate.[88][Level of evidence B3] The FDA approved capmatinib for patients with metastatic NSCLC and MET exon 14-skipping variants.

The most common treatment-related adverse events were peripheral edema (n = 174; 47%), nausea (n = 130; 35%), increased blood creatinine (n = 78; 21%), and vomiting (n = 74; 20%). Grade 3 to 4 serious adverse events occurred in 44% of patients, with dyspnea as the most common (occurring in 5% of patients).