Abstract
Background: HER2 exon 20 insertion mutations (exon20ins) are oncogenic driver mutations detected in 1∼3% of non-small cell lung cancer (NSCLC) patients in the US. Currently, there are no FDA- or EMA-approved targeted therapies for these patients. Development of small molecule inhibitors for HER2 exon20ins has been limited by off-target inhibition of closely related wild-type EGFR, which can lead to adverse events and dose-limiting toxicities including skin rash and gastrointestinal toxicity. In addition, activity in the central nervous system (CNS) is needed, since ∼20% of HER2 exon20ins NSCLC patients present with accompanying brain metastases at the time of diagnosis.
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