HER3-targeted ADC for patients with drug-resistant non-small cell lung cancer
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HER3-targeted ADC is recognized as a breakthrough therapy for the treatment of patients with drug-resistant non-small cell lung cancer.
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 conjugate drug (ADC), used for the treatment of third-generation tyrosine kinase inhibitors (TKI) and platinum-containing therapy during or during treatment Later, patients with metastatic or locally advanced non-small cell lung cancer (NSCLC) who have disease progression and carry drug-resistant EGFR mutations.
Lung cancer is the world’s second most common cancer and the leading cause of cancer-related deaths, of which 80%-85% are NSCLC. Approximately 15%-50% of NSCLC patients carry EGFR mutations.
Although the efficacy of epidermal growth factor receptor (EGFR) TKI targeted therapy in advanced NSCLC with EGFR mutations (approximately 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 4.4-6.4 months.
About 83% of tumor cells in NSCLC patients with EGFR mutations express HER3 protein. HER3 is a member of the EGFR family of receptor tyrosine kinases, which is related to abnormal cell proliferation and survival, and may be related to increased incidence of metastasis, decreased survival rate, and resistance to standard therapies.
Patritumab deruxtecan is designed with 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 through a tetrapeptide linker.
Introduction of Patritumab deruxtecan (U3-1402) (Image source: Daiichi Sankyo official website)
This breakthrough therapy designation is based on the positive data currently obtained in a three-cohort phase 1 clinical trial of the drug.
The results published in the American Society of Clinical Oncology (ASCO) in 2021 showed that 57 enrolled patients treated with patritumab deruxtecan (5.6 mg/kg) had an objective response rate (ORR) of 39% (CI 95%: 26-52%) ), the disease control rate was 72% (CI 95%: 59-83%), and the median progression-free survival (PFS) was 8.2 months.
In terms of safety, the safety profile in patients (n=57) who received the 5.6 mg/kg dose was consistent with previous studies.
References:
[1] Patritumab Deruxtecan Granted U.S. FDA Breakthrough Therapy Designation in Patients with Metastatic EGFR-Mutated Non-Small Cell Lung Cancer. Retrieved December 23, 2021, from https://www.daiichisankyo.com/files/news/pressrelease/pdf/202112/20211223_E1.pdf
HER3-targeted ADC for patients with drug-resistant non-small cell lung cancer
(source:internet, reference only)
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