AstraZeneca and Daiichi Sankyo announced that in the United States, Enhertu was granted Priority Review for patients with HER2-mutant metastatic non-small cell lung cancer who had previously been treated.
The supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) for the treatment of adult patients in the United States with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have a HER2 (ERBB2) mutation and who have received prior systemic therapy has been accepted, according to AstraZeneca and Daiichi Sankyo. Priority Review has also been given to the application.
AstraZeneca and Daiichi Sankyo are working together on Enhertu, a HER2-directed antibody-drug conjugate (ADC).
Priority Review is granted by the Food and Drug Administration (FDA) to applications for medicines that, if approved, would provide significant benefits over existing options by demonstrating improved safety or efficacy, averting serious conditions, or improving patient compliance.
The FDA action date for their regulatory decision under the Prescription Drug User Fee Act (PDUFA) is in the third quarter of 2022.
The FDA approved Enhertu Breakthrough Therapy Designation in this cancer type in May 2020, prompting the Priority Review for AstraZeneca.
Lung cancer is the second most frequent disease worldwide, with over two million new cases expected to be diagnosed by 2020.
Patients with metastatic NSCLC have a particularly bad prognosis, with just about 8% living longer than five years following diagnosis.
There are presently no HER2-directed treatments licenced particularly for the treatment of HER2-mutant NSCLC4, which affects 2%-4% of non-squamous NSCLC patients.
Supplemental Biologics License Application
The sBLA is supported by the Phase I trial published in Cancer Discovery and is based on results from the registrational DESTINY-Lung01 Phase II trial published in The New England Journal of Medicine.
As assessed by independent central review, primary results from previously-treated patients with HER2-mutations of DESTINY-Lung01 revealed a confirmed objective response rate of 54.9% in patients treated with Enhertu (6.4mg/kg).
A total of one (1.1%) complete response and 49 (53.8%) partial replies were found.
A proven disease control rate of 92.3% was recorded, with most patients experiencing a reduction in tumour size.
AstraZeneca’s Enhertu’s median duration of response was 9.3 months after a median follow-up of 13.1 months.
The median progression-free survival was 8.2 months, with a 17.8-month median overall survival.
In DESTINY-Lung01, the safety profile of the most prevalent adverse events with Enhertu was consistent with prior clinical trials, and no new safety issues were detected.
AstraZeneca’s Enhertu is currently being evaluated in a large clinical trial that will look at its efficacy and safety in a variety of HER2-targetable malignancies, including breast, gastric, lung, and colorectal cancers.
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, commented, ” The DESTINY-Lung01 trial confirmed the HER2 mutation as an actionable biomarker in non-small cell lung cancer.”
“If approved, Enhertu has the potential to become a new standard treatment in this patient population, offering a much-needed option for patients with HER2-mutant metastatic non-small cell lung cancer who currently have no targeted treatment options.”
“The results of DESTINY-Lung01 showed that Enhertu is the first HER2-directed therapy to demonstrate a strong and robust tumour response in more than half of patients with previously treated HER2-mutant metastatic non-small cell lung cancer,” added Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo.
“Seeking approval in the US for a third tumour type in three years further demonstrates the significant potential of Enhertu in treating multiple HER2-targetable cancers.”
AstraZeneca shares dropped 0.1% to 10,526p on Tuesday despite announcing the Priority Review for Enhertu.