Positive topline results in phase 3 trial for Enhertu for patients with HER2 Mutant Advanced Non-Small Cell Lung Cancer – Daiichi Sankyo and AstraZeneca

Positive topline results from the DESTINY-Lung04 phase 3 trial showed Enhertu (trastuzumab deruxtecan) 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 first-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.

Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

Global standard of care for patients with HER2 mutant NSCLC in the first-line metastatic setting is a combination of immunotherapy and platinum-based chemotherapy. However, many patients do not respond to first-line treatment and experience disease progression, underscoring the need for additional treatment options. Approximately 2% to 4% of patients with NSCLC have tumors with a HER2 mutation.

The safety profile of Enhertu observed in DESTINY-Lung04 was generally consistent with its known profile with no new safety concerns identified.

Enhertu is currently approved in more than 80 countries/regions to treat patients with previously treated metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations and in more than 45 countries/regions to treat patients with HER2 positive solid tumors, including HER2 overexpressing metastatic NSCLC, who have received prior treatment and who have no satisfactory treatment options.