Early-Phase Trial Studies Capmatinib in Advanced NSCLC
Posted: Monday, April 13, 2020
Approximately 3% to 4% of patients with non–small cell lung cancer (NSCLC) possess a dysregulation of receptor tyrosine kinase MET, a mutation that is associated with an unfavorable prognosis. A study published in the Annals of Oncology found that treatment with capmatinib appears to be well tolerated and may be effective in some patients with advanced MET-dysregulated NSCLC.
The research of Martin Schuler, MD, of the West German Cancer Center, University Hospital Essen, Germany, and colleagues, indicated that overexpression of this gene alone may not be a reliable biomarker to predict the efficacy of capmatinib. However, the researchers discovered that a MET gene copy number of at least 6 (MET GCN ≥ 6) and/or splice-site alterations involving exon 14 (METex14) seem to be indicators for predicting clinical activity.
A total of 55 patients with advanced MET-dysregulated NSCLC were enrolled in the phase I trial. Participants received capmatinib as 400-mg tablets twice daily or 600-mg capsules twice daily. Most participants, 73%, had received at least two prior systemic therapies.
The median duration of treatment was 10.4 weeks. All patients discontinued treatment, most due to disease progression (69.1%). The objective response rate was 20% in the overall study population, but it was higher (47%) in patients with MET GCN ≥ 6.
All patients had at least one adverse event during the study. The most frequent study-related toxicities at any grade included nausea (42%), peripheral edema (33%), and vomiting (31%), with the most common drug-related grade 3 or 4 adverse events were nausea, peripheral edema, and fatigue.
“Overall, capmatinib has an acceptable safety profile,” stated the authors. “Even when combined with other tyrosine kinase inhibitors, it was well tolerated.”
Disclosure: For full disclosures of the study authors, visit www.annalsofoncology.org.