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• W4387117515 abstract "Treatment options for treatment-naïve patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations are limited. This study evaluated the safety, tolerability, pharmacokinetics of YK-029A, a third-generation EGFR tyrosine kinase inhibitor, and the preliminary efficacy of YK-029A in treatment-naïve patients with EGFR ex20ins mutation.This multicenter, dose-escalation, and dose-expansion phase I clinical trial enrolled patients with NSCLC harboring EGFR mutations. During the dose-escalation phase, YK-029A was orally administered using the traditional 3+3 principle at 50, 100, 150, 200, and 250 mg/day. In the dose-expansion phase, treatment-naïve patients with EGFR ex20ins mutations were enrolled and administered YK-029A 200 mg/day. The primary endpoint was safety and tolerability.The safety analysis included 108 patients. No dose-limiting toxicity was observed, and the maximum tolerated dose was not reached. The most common treatment-emergent adverse events were anemia (50.9%), diarrhea (49.1%), and rash (34.3%). There was minimal drug accumulation after multiple doses. Twenty-eight treatment-naïve patients with EGFR ex20ins mutations were enrolled in the dose-expansion, and 26 were included in the efficacy analysis. According to the independent review committee evaluation, the objective response rate was 73.1% (95% confidence interval [CI], 52.21% to 88.43%), and the disease control rate was 92.3% (95% CI, 74.87% to 99.05%).YK-029A showed manageable safety and was tolerable in patients with NSCLC harboring EGFR mutations and showed promising antitumor activity in untreated patients with EGFR ex20ins mutations." @default.
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• W4387117515 date "2023-09-01" @default.
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• W4387117515 title "Safety, tolerability, pharmacokinetics, and preliminary efficacy of YK-029A in treatment-naïve patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations: A phase I trial" @default.
• W4387117515 doi "https://doi.org/10.1016/j.jtho.2023.09.1449" @default.
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