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On December 24, Daiichi Sankyo announced that the US FDA has granted patritumab deruxtecan (HER3-DXd) breakthrough therapy designation (BTD)
This is a potential "first-in-class" HER3 targeting antibody-conjugated drug (ADC) for the treatment of third-generation tyrosine kinase inhibitors (TKI) and platinum-containing therapy during treatment
Lung cancer is the second most common cancer in the world and the leading cause of cancer-related deaths, of which 80%-85% are non-small cell lung cancer
Although the efficacy of epidermal growth factor receptor (EGFR) TKI targeted therapy for advanced NSCLC with EGFR mutations (about 30% of patients) has been fully verified, the drug resistance produced by the treatment usually leads to disease progression
After the failure of EGFR TKI, the efficacy of platinum-containing chemotherapy is limited, and the patient's progression-free survival (PFS) is only about 4.
In NSCLC patients with EGFR mutations, about 83% of tumor cells express HER3 protein
Patritumab deruxtecan is designed using Daiichi Sankyo’s proprietary DXd ADC technology, and is composed of a humanized anti-her3 antibody and a topoisomerase I inhibitor (topoisomerase I inhibitor) payload connected by a tetrapeptide connector
Introduced Partuzumab deruxtecan (U3-1402) (Image source: Daiichi Sankyo official website)
This breakthrough treatment plan is based on the positive data currently obtained from three cohort phase 1 clinical trials of the drug
The results were published in the American Society of Clinical Oncology (ASCO 2021) and showed that 57 patients registered with patritumab deruxtecan (5.
In terms of safety, the safety of patients who received the 5.