Savolitinib Plus Gefitinib May Be Effective in EGFR-Mutant, MET-amplified NSCLC
Researchers administered savolitinib 600 mg plus gefitinib 250 mg to 44 patients, of whom 6 were T790M-positive and 5 were T790M-negative.
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Savolitinib plus gefitinib may have clinical efficacy and a favorable safety profile for patients with EGFR-mutant, MET-amplified non–small cell lung cancer (NSCLC) who progress after EGFR-TKI treatment, according to a study presented at the International Association for the Study of Lung Cancer (IASLC) 18th Annual World Conference on Lung Cancer (WCLC) in Japan.1
For this open-label, phase 1b study (ClinicalTrials.gov Identifier: NCT02374645), researchers administered savolitinib 600 mg plus gefitinib 250 mg to 44 patients (aged 18 years and older; median age 61 years), of whom 6 were T790M-positive and 5 were T790M-negative. Patients underwent central screenings for MET-amplification and evaluations of EGFR. Forty-six percent of patients were still receiving study treatment at the 3-month assessment.
Eleven (25%) patients had confirmed partial responses of anti-tumor activity; 4 patients are awaiting confirmation of response.
The most frequently reported adverse events (AEs) were vomiting (41%), nausea (39%), rash (36%), elevated ALT levels (32%), elevated AST levels (30%), hypoalbuminaemia (25%), gamma-glutamyl transpeptidase increase (25%), and elevation of blood alkaline phosphatase (21%). Grade 3 or worse AEs were reported in 32% of patients.
There were 3 deaths due to AEs but none were considered treatment-related.
The authors concluded that “these encouraging findings warrant further assessment of savolitinib plus gefitinib for patients with EGFR-mutant, MET-amplified NSCLC who progressed on prior EGFR-TKI.”
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- Yang JJ, Fang J, Shu Y, et al. A phase Ib trial of savolitinib plus gefitinib for chinese patients with EGFR-mutant MET-amplified advanced NSCLC. Presented at: International Association for the Study of Lung Cancer 18th World Conference on Lung Cancer; October 2017; Yokohama, Japan. Abstract OA 09.06.