Daiichi Sankyo Company has dosed the first patient in its Phase I trial that aims to evaluate safety and tolerability of U3-1402 in patients with metastatic or unresectable epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC), whose disease has progressed, while taking an EGFR tyrosine kinase inhibitor (TKI).

The open-label, two-part study expects to enrol more than 60 patients at around 17 sites worldwide.

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Primary endpoints are to evaluate the safety and tolerability of U3-1402 and determine the recommended dose for the increase part of the study.

Secondary objectives of the trial are to characterise U3-1402’s pharmacokinetics and to evaluate preliminary efficacy by measuring anti-tumour activity of U3-1402.

“We are exploring whether the smart delivery of chemotherapy with U3-1402 to cancer cells that express HER3 could become a new treatment strategy for these patients.”

Daiichi Sankyo oncology research and development executive vice-president and global head Antoine Yver said: “While the treatment of metastatic EGFR-mutated NSCLC has significantly improved over the past decade, new treatments are needed that work to overcome resistance associated with current EGFR TKIs.

“In this study, we are exploring whether the smart delivery of chemotherapy with U3-1402 to cancer cells that express HER3, a known feature of resistance in pre-treated EGFR-mutated NSCLC, could become a new treatment strategy for these patients.”

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Daiichi Sankyo is currently carrying out two Phase I clinical studies to evaluate U3-1402, an investigational agent and potential HER3-targeting antibody-drug conjugate (ADC).

The company noted that treatment with EGFR TKIs such as erlotinib, gefitinib, or afatinib is used as first-line therapy for metastatic EGFR-mutated NSCLC, but patients are reported to be eventually developing resistance to these treatments, typically experiencing disease progression within a year.