Enhertu Receives FDA Priority Review for Previously Treated HER2-Mutant Metastatic Non-Small Cell Lung Cancer

Today, AstraZeneca and Daiichi Sankyo jointly announced that the supplemental Biologics License Application (sBLA) for their jointly developed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has been granted Priority Review by the U.S. FDA for the treatment of patients with unresectable or metastatic non-small cell lung cancer (NSCLC) harboring HER2 mutations who have previously received one systemic therapy.

Lung cancer is the second most common type of cancer globally, with over 2 million newly diagnosed patients in 2020. The prognosis for patients with metastatic NSCLC is particularly poor, as only about 8% of patients survive beyond five years after diagnosis. Currently, there are no approved HER2-targeted therapies specifically for treating NSCLC patients carrying HER2 mutations.

Enhertu is an ADC therapy jointly developed by AstraZeneca and Daiichi Sankyo. It is designed using Daiichi Sankyo's proprietary DXd ADC technology platform, consisting of a humanized monoclonal antibody targeting HER2 linked to a topoisomerase 1 inhibitor payload via a cleavable tetrapeptide linker. Enhertu has previously received FDA approval as a third-line treatment for patients with HER2-positive unresectable or metastatic HER2-positive breast cancer, as well as for patients with HER2-positive locally advanced or metastatic gastric cancer and gastroesophageal junction (GEJ) adenocarcinoma who have been treated with trastuzumab-based therapies.

This sBLA is primarily based on the positive results of the registrational phase 2 clinical trial DESTINY-Lung01. The trial results showed that, in previously treated NSCLC patients with HER2 mutations, Enhertu achieved a confirmed objective response rate of 54.9%. The disease control rate reached 92.3%, with tumor shrinkage observed in the majority of patients.

At a median follow-up time of 13.1 months, the median duration of response was 9.3 months, the median progression-free survival was 8.2 months, and the median overall survival was 17.8 months. This result has been published in The New England Journal of Medicine.

AstraZeneca's Executive Vice President of Oncology R&D, Dr. Susan Galbraith, said: "The DESTINY-Lung01 clinical trial validated that HER2 gene mutations are targetable biomarkers in non-small cell lung cancer. If approved, Enhertu has the potential to become the new standard treatment for this patient population."

References:

[1] Enhertu granted Priority Review in the US for patients with previously treated HER2-mutant metastatic non-small cell lung cancer. Retrieved April 19, 2022, from https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/enhertu-granted-priority-review-for-her2m-nsclc.html

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