AstraZeneca and Daiichi Sankyo have received notification of acceptance concerning the supplemental Biologics License Application of Enhertu (trastuzumab deruxtecan).
The therapy treats adult patients in the US with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have a HER2 (ERBB2) mutation and who have received a prior systemic therapy. While HER2 gene mutations can occur in a range of patients, they are more commonly found in those with NSCLC who are younger, female and have never smoked.
The application has also been granted priority review, which the US Food and Drug Administration (FDA) provides to medicine applications that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.
Enhertu is being further assessed in a comprehensive clinical development programme evaluating efficacy and safety across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers.
Meanwhile, the safety profile of the most common adverse events with Enhertu in DESTINY-Lung01 was consistent with previous clinical trials with no new safety concerns identified.
News of the priority review has brought optimism from both companies involved in the pioneering collaboration.
Susan Galbraith, executive vice president, oncology R&D at AstraZeneca, said: “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.”
Ken Takeshita, global head, R&D at Daiichi Sankyo, added: “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.
“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,” he concluded.
Across the world, lung cancer remains the second most common form of the disease, with more than two million new cases diagnosed in 2020. For patients with metastatic NSCLC, prognosis is particularly poor, as only approximately 8% will live beyond five years after diagnosis.