AstraZeneca and Daiichi Sankyo Recommend for Approval of Enhertu

Enhertu, developed jointly by AstraZeneca and Daiichi Sankyo, has received a recommendation for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC). 

This recommendation applies to patients whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

Enhertu is a specifically engineered antibody-drug conjugate (ADC) directed at HER2. It comprises a HER2 monoclonal antibody linked to a topoisomerase I inhibitor payload, which is an exatecan derivative. This linkage is achieved through a stable tetrapeptide-based cleavable linker.

In the clinical trial, Enhertu administered at a dose of 5.4mg/kg exhibited a confirmed objective response rate (ORR) of 49.0 percent (with a 95 percent confidence interval [CI] ranging from 39.0 to 59.1 percent) and a disease control rate (DCR) of 93.1 percent in patients who had previously received treatment for advanced or metastatic HER2-mutant (HER2m) non-small cell lung cancer (NSCLC).

Previously, Enhertu had received approval in more than 50 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. These patients had received one or more prior anti-HER2-based regimens, either in the metastatic setting, or in the neoadjuvant or adjuvant setting, and had developed disease recurrence during or within six months of completing therapy.

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