Healthcare
ENHERTU® (fam-trastuzumab deruxtecan-nxki) demonstrated statistically significant and clinically meaningful improvement in PFS as 1st-line treatment of patients with HER2-mutant advanced non-small cell lung cancer in DESTINY-Lung04 Phase III trial
WILMINGTON, Del., August 17, 2026--Positive high-level results from the DESTINY-Lung04 Phase III trial showed ENHERTU® (fam-trastuzumab deruxtecan-nxki) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus global standard of care (platinum-pemetrexed doublet chemotherapy plus pembrolizumab) as 1st-line treatment of patients with unresectable, locally advanced or metastatic HER2-mutant non-squamous non-small cell lung cancer (NSC
About this update from Astrazeneca Plc
AstraZeneca and Daiichi Sankyo's ENHERTU is the first and only HER2-directed medicine to improve progression-free survival over global standard of care in a Phase III trial in this setting WILMINGTON, Del., August 17, 2026--(BUSINESS WIRE)--Positive high-level results from the DESTINY-Lung04 Phase III trial showed ENHERTU® (fam-trastuzumab deruxtecan-nxki) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus global standard of care (platinum-pemetrexed doublet chemotherapy plus pembrolizumab) as 1st-line treatment of patients with unresectable, locally advanced or metastatic HER2-mutant non-squamous non-small cell lung cancer (NSCLC). The trial will continue as planned to evaluate secondary endpoints including overall survival. The global standard of care for patients with HER2-mutant NSCLC in the 1st-line metastatic setting is a combination of immunotherapy and platinum-based chemotherapy.1-3 However, many patients do not respond to 1st-line treatment and experience disease progression, underscoring the need for additional treatment options.3-7 Approximately 2-4% of patients with NSCLC have tumors with a HER2 mutation.8-10 Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "Our oncology pipeline continues to advance with DESTINY-Lung04 becoming the first Phase III trial to demonstrate a progression-free survival benefit versus the global standard of care in this 1st-line setting, supporting the potential for ENHERTU to move earlier in the treatment of HER2-mutant non-small cell lung cancer. This aggressive lung cancer often affects younger patients and has historically had limited 1st-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." John Tsai, Global Head, R&D, Daiichi Sankyo, said: "ENHERTU is already established as the first and only antibody drug conjugate for the 2nd-line treatment of HER2-mutant metastatic non-small cell lung cancer. The positive results seen in DESTINY-Lung04 show that treatment with ENHERTU in the 1st-line setting delays disease progression compared to the global standard of care, highlighting its potential to improve outcomes for patients ear...