Daiichi Sankyo and AstraZeneca’s Enhertu has delivered positive results in HER2 mutant NSCLC through the DESTINY-Lung04 phase 3 trial. The treatment achieved a statistically significant and clinically meaningful improvement in progression-free survival (PFS).
The results compare Enhertu against the global standard of care in the first-line treatment setting. Platinum-pemetrexed doublet chemotherapy with pembrolizumab is the standard of care. The DESTINY-Lung04 trial enrolled patients with unresectable, locally advanced or metastatic HER2 mutant non-squamous non-small cell lung cancer (NSCLC). The positive topline results support the continued progress of the trial as planned.
The study will assess additional secondary endpoints, including overall survival. Meanwhile, the companies plan to present the findings at an upcoming medical meeting. They will also share the data with global regulatory authorities for further evaluation.
Enhertu is a specifically engineered HER2 directed DXd antibody-drug conjugate (ADC). Daiichi Sankyo discovered the medicine and jointly developed it with AstraZeneca. The companies also jointly commercialize Enhertu across global markets. The treatment targets HER2, which can play an important role in certain forms of cancer.
Today the standard of care worldwide is immunotherapy in combination with platinum-based chemotherapy. For first-line metastatic HER2-mutant NSCLC, this is a common approach for doctors. But some patients do not have an adequate response to first-line therapy. Many patients also experience disease progression following first-line therapy.
Therefore, additional treatment options remain important for patients and healthcare providers. HER2 mutations occur in approximately 2% to 4% of patients with NSCLC. This patient population highlights the need for effective targeted therapies. Consequently, the DESTINY-Lung04 findings could strengthen the role of HER2-directed treatment.
“Enhertu is already established as the first and only antibody drug conjugate for the second-line treatment of HER2 mutant metastatic non-small cell lung cancer,” said John Tsai, MD, Global Head of R&D, Daiichi Sankyo. “The positive results seen in DESTINY-Lung04 show that treatment with Enhertu in the first-line setting delays disease progression compared to the global standard of care, highlighting its potential to improve outcomes for patients earlier in the treatment of metastatic disease.”
DESTINY-Lung04 Supports Earlier Enhertu Use
The latest findings could support moving Enhertu into earlier treatment for eligible patients. The phase 3 trial demonstrated a progression-free survival benefit against the global standard of care.
“Our oncology pipeline continues to advance with DESTINY-Lung04 becoming the first phase 3 trial to demonstrate a progression-free survival benefit versus the global standard of care in this first-line setting, supporting the potential for Enhertu to move earlier in the treatment of HER2 mutant non-small cell lung cancer,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology R&D, AstraZeneca. “This aggressive lung cancer often affects younger patients and has historically had limited first-line targeted treatment options, making these positive results an important step forward in bringing additional effective therapies to patients at metastatic diagnosis when there is the greatest opportunity to improve outcomes.”
The safety profile reported in DESTINY-Lung04 remained generally consistent with Enhertu’s known safety profile. Importantly, the trial identified no new safety concerns. The companies will present the DESTINY-Lung04 data at an upcoming medical meeting. They will also provide the findings to regulatory authorities worldwide.
Enhertu Shows First-Line Treatment Potential
Enhertu currently holds approvals across more than 80 countries and regions. These approvals cover previously treated metastatic NSCLC with activating HER2 (ERBB2) mutations. Additionally, Enhertu has approvals in more than 45 countries and regions for HER2-positive solid tumors. This includes HER2-overexpressing metastatic NSCLC after previous treatment.
Patients must have no satisfactory treatment options under the applicable approvals. The latest DESTINY-Lung04 findings could further expand interest in HER2 mutant NSCLC treatment.
The findings represent another step forward for Enhertu in lung cancer overall. They also support the potential of HER2-directed antibody-drug conjugates in oncology. With more data, the companies will continue to evaluate the role of Enhertu in HER2-mutant NSCLC. The upcoming overall survival results will provide more information on the clinical benefit of this treatment.
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News Source: Businesswire.com
