China grants conditional approval for ENHERTU to treat NSCLC

Daiichi Sankyo and AstraZeneca's ENHERTU has achieved conditional approval from China's National Medical Products Administration (NMPA) for use as a standalone treatment in adults with a specific non-small cell lung cancer (NSCLC). This approval is targeted at patients with unresectable or metastatic NSCLC harboring activating HER2 mutations who have previously received systemic therapy.

This recent authorization signifies the fourth approval for ENHERTU in China, which already includes treatments for HER2-low metastatic breast cancer and HER2-positive advanced or metastatic gastric cancer. ENHERTU is a HER2-directed antibody-drug conjugate (ADC) developed by Daiichi Sankyo in collaboration with AstraZeneca.

The approval is underpinned by results from the DESTINY-Lung02 and DESTINY-Lung05 Phase II clinical trials. In the DESTINY-Lung02 study, ENHERTU demonstrated a confirmed overall response rate (ORR) of 49%, which included 49 partial responses (PRs) and one complete response (CR), according to a blinded independent central review (BICR). The DESTINY-Lung05 trial reported a confirmed ORR of 58.3%, consisting of one CR and 41 PRs, as assessed by independent central review (ICR).

Dave Fredrickson, Executive Vice-President of the Oncology Business Unit at AstraZeneca, commented on the significance of this approval. He emphasized that this marks the first approval in China of a HER2-directed therapy specifically for treating HER2 mutant metastatic non-small cell lung cancer. Fredrickson highlighted the importance of testing for predictive biomarkers, such as HER2 mutations in lung cancer, at diagnosis to ensure patients receive appropriate treatments tailored to their specific disease.

The final approval of ENHERTU for this indication in China will depend on the results observed in confirmatory clinical trials. ENHERTU was also approved in the United States in April 2024 as the first tumor-agnostic HER2-directed therapy for patients with previously treated metastatic HER2-positive solid tumors.

This development represents a significant advancement in the treatment landscape for specific NSCLC patients, offering hope for improved outcomes through targeted therapies.