Drug intelligence / Profile preview

zipalertinib + chemotherapy

Development stage
Unknown
Lead developer
Taiho Pharmaceutical
Modality
Classical Binding Small Molecules → Small Molecules, Covalent Small Molecules → Small Molecules, Nucleic Acid-Directed Small Molecules → Small Molecules
Administration
Oral, Intravenous
01

Overview

Zipalertinib + chemotherapy is a combination drug regimen currently under investigation for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Zipalertinib (CLN-081/TAS6417) is an orally available, next-generation, irreversible EGFR tyrosine kinase inhibitor with a novel pyrrolopyrimidine scaffold, offering potent and selective inhibition of mutant EGFR while sparing wild-type EGFR. In the pivotal REZILIENT3 Phase 3 trial, zipalertinib is combined with first-line standard-of-care platinum-based chemotherapy (pemetrexed plus cisplatin or carboplatin). The aim of this combination is to increase anti-tumor efficacy compared to chemotherapy or EGFR TKI therapy alone, as supported by prior clinical evidence in EGFR-mutant NSCLC. Zipalertinib has demonstrated favorable tolerability, with a low frequency of high-grade rash and diarrhea, and has received Breakthrough Therapy Designation from the FDA for this indication[2][1][3][5][6][9].

Other names
zipalertinib + chemotherapy
02

Targets

Epidermal growth factor receptor G719X mutantEGFR L858R (Epidermal growth factor receptor L858R mutant)Epidermal growth factor receptor (EGFR) S768I mutantEGFR T790M (Epidermal growth factor receptor T790M mutant)EGFR exon 19del (Epidermal growth factor receptor exon 19 deletion mutant)EGFR ex20ins (Epidermal growth factor receptor exon 20 mutant)EGFR (Epidermal growth factor receptor)

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