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AstraZeneca and Daiichi Sankyo's Enhertu Secures Conditional Approval in China for HER2-Mutated NSCLC Treatment

NextEdge Admin

15 Oct 2024

2 min 49 sec

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has received conditional approval from China’s National Medical Products Administration (NMPA) for use as a monotherapy in adult patients with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) harboring activating HER2 (ERBB2) mutations. This approval applies to patients who have previously undergone systemic therapy. The decision is based on promising results from the DESTINY-Lung02 and DESTINY-Lung05 Phase II trials, with full approval contingent upon the success of confirmatory trials.

Lung cancer is a significant health burden in China, with over one million new cases annually—more than 40% of the global total. Among NSCLC cases, 2-4% involve HER2 mutations, representing a population with limited treatment options. Ying Cheng, MD, PhD, principal investigator of DESTINY-Lung05, emphasized that Enhertu offers a critical new option for patients with this challenging subtype of NSCLC.

Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, highlighted that Enhertu is the first HER2-directed therapy approved in China for HER2-mutant metastatic NSCLC. He stressed the importance of biomarker testing, including HER2, to optimize patient outcomes. Kiminori Nagao, head of Daiichi Sankyo’s Asia, South & Central America Business Unit, noted that this approval follows prior approvals for HER2-positive breast and gastric cancers, underscoring Enhertu’s benefit across multiple HER2-driven cancers.

In DESTINY-Lung02, Enhertu achieved an objective response rate (ORR) of 49.0% and a median duration of response (DoR) of 16.8 months. DESTINY-Lung05, which focused on Chinese patients, demonstrated a higher ORR of 58.3%. The drug’s safety profile was consistent with previous trials, with no new safety issues identified.

Enhertu is co-developed by AstraZeneca and Daiichi Sankyo and is approved in over 45 countries, including the US, Japan, and the EU, for HER2-mutant NSCLC.