The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to patritumab deruxtecan (HER3-DXd) for the treatment of patients with metastatic or locally advanced EGFR-mutated non-small cell lung cancer (NSCLC) with disease progression on or after treatment with a third-generation tyrosine kinase inhibitor (TKI) and platinum-based therapies.
Patritumab deruxtecan is a potential first-in-class HER3-directed antibody drug conjugate. The investigational treatment consists of a fully human anti-HER3 IgG1 monoclonal antibody attached to a topoisomerase I inhibitor payload (an exatecan derivative, DXd) via a stable tetrapeptide-based cleavable linker.
The designation was based on data from the dose escalation portion and 2 expansion cohorts of a 3-cohort phase 1 study (ClinicalTrials.gov Identifier: NCT04676477) of patritumab deruxtecan. Preliminary evidence showed that treatment with patritumab deruxtecan had a clinically meaningful and durable tumor response in patients with locally advanced or metastatic TKI-resistant, EGFR-mutated NSCLC.
“The Breakthrough Therapy Designation for patritumab deruxtecan acknowledges the need for new treatment approaches to overcome resistance and improve survival in patients with metastatic TKI-resistant, EGFR-mutated non-small cell lung cancer,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “We are proud that the FDA has once again recognized our innovative science and technology and we look forward to bringing this potential first-in-class HER3 directed antibody drug conjugate to patients with this specific type of lung cancer as quickly as possible.”
- Patritumab deruxtecan granted US FDA Breakthrough Therapy designation in patients with metastatic EGFR-mutated non-small cell lung cancer. News release. Daiichi Sankyo Company, Limited. December 23, 2021. Accessed December 27, 2021. https://www.businesswire.com/news/home/20211222005517/en/Patritumab-Deruxtecan-Granted-U.S.-FDA-Breakthrough-Therapy-Designation-in-Patients-with-Metastatic-EGFR-Mutated-Non-Small-Cell-Lung-Cancer
- Patritumab deruxtecan data at ASCO demonstrates tumor response across multiple resistance mechanisms in patients with advanced EGFR-mutated NSCLC. News release. Daiichi Sankyo Company, Limited. June 4, 2021. Accessed December 27, 2021. https://www.daiichisankyo.com/files/news/pressrelease/pdf/202106/20210604_E.pdf