Today, AstraZeneca and Daiichi Sankyo jointly announced that the supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan), their jointly developed antibody drug conjugate (ADC), has been granted by the U.
FDA for the treatment of patients with unresectable or metastatic non-small cell lung cancer (NSCLC) harboring HER2 mutations
They had previously received an upfront systemic therapy
Lung cancer is the second most common type of cancer worldwide, with more than 2 million newly diagnosed patients in 2020
Patients with metastatic NSCLC have a particularly poor prognosis, with only about 8% of patients living beyond 5 years after diagnosis
There are currently no approved HER2-targeted therapies for the targeted treatment of NSCLC patients with HER2 mutations
Enhertu is an ADC therapy jointly developed by AstraZeneca and Daiichi Sankyo
Designed using Daiichi Sankyo's proprietary DXd ADC technology platform, it consists of a humanized monoclonal antibody targeting HER2 linked to a topoisomerase 1 inhibitor payload via a tetrapeptide cleavable linker
Enhertu has previously been FDA-approved as a third-line treatment for patients with previously treated HER2-positive unresectable or metastatic HER2-positive breast cancer, as well as HER2-positive locally advanced or metastatic gastric cancer and gastroesophageal junction (GEJ) glands treated with trastuzumab-based therapy cancer patients
This sBLA is based primarily on positive results from the registrational Phase 2 clinical trial DESTINY-Lung01
Trial results showed that Enhertu achieved a confirmed objective response rate of 54.
9% in previously treated NSCLC patients with HER2 mutations
The disease control rate was 92.
3%, and tumor shrinkage was observed in the majority of patients
At a median follow-up 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.
The results have been published in the New England Journal of Medicine
Dr Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "The DESTINY-Lung01 clinical trial validates HER2 gene mutation as a targetable biomarker in non-small cell lung cancer
If approved, Enhertu has the potential to become a novelty in this patient population.
potential for standard care
 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:// /press-releases/2022/enhertu-granted-priority-review-for-her2m-nsclc.