AstraZeneca and Daiichi Sankyo’s Enhertu Approved in China as First HER2-Targeted Therapy for Non-Small Cell Lung Cancer (NSCLC)
Monday, October 14, 2024
AstraZeneca and Daiichi Sankyo’s Enhertu has gained conditional approval in China as a standalone treatment for adults with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) featuring activating HER2 (ERBB2) mutations.
DESTINY-Lung02 is a global, randomised Phase II trial assessing the safety and efficacy of Enhertu in patients with HER2-mutant unresectable and/or metastatic NSCLC who experienced disease recurrence or progression after at least one previous anticancer treatment that included platinum-based chemotherapy. Participants were randomised to receive either Enhertu at 5.4mg/kg or 6.4mg/kg.
DESTINY-Lung05 is an open-label, single-arm Phase II trial examining the safety and efficacy of Enhertu (5.4mg/kg) in patients with HER2-mutant metastatic NSCLC who have seen disease progression after at least one prior anticancer therapy.
This approval is for patients who have already undergone systemic therapy.
The National Medical Products Administration (NMPA) granted this conditional approval based on the positive outcomes from the DESTINY-Lung02 and DESTINY-Lung05 Phase II trials. Full approval will depend on the results of a confirmatory trial demonstrating clinical benefit.
In China, over one million individuals are diagnosed with lung cancer annually, making up more than 40% of the global lung cancer cases, with many patients diagnosed at advanced stages. Approximately 2% to 4% of NSCLC patients possess tumours with activating HER2 mutations.
Enhertu is a specially engineered HER2-directed antibody drug conjugate developed by Daiichi Sankyo and is being co-developed and commercialised by AstraZeneca and Daiichi Sankyo.
Enhertu’s approval marks a significant advancement for patients with HER2-mutant NSCLC, who have historically had limited treatment options. Enhertu represents a targeted therapy for this aggressive form of lung cancer.
This approval is notable as it is the first HER2-targeted therapy sanctioned in China for HER2-mutant metastatic NSCLC, highlighting the need for predictive biomarker testing, including HER2 mutations, at diagnosis to ensure patients receive the most appropriate treatment.
Since its initial approval for HER2-positive metastatic breast cancer in China last year, Daiichi Sankyo has been dedicated to providing Enhertu to more patients, including those previously ineligible for HER2-targeted therapies.
This latest approval is the fourth for Enhertu in China, following its recent sanction for HER2-positive metastatic gastric cancer, which underscores its benefits across various HER2-targetable cancers.
In the DESTINY-Lung02 trial, which involved patients from Japan, Korea, and Taiwan, Enhertu (5.4mg/kg) showed a confirmed objective response rate (ORR) of 49.0%, as evaluated by blinded independent central review (BICR).
The median duration of response (DoR) was 16.8 months, with a median progression-free survival (PFS) of 9.9 months and a median overall survival (OS) of 19.5 months.
In DESTINY-Lung05, Enhertu (5.4mg/kg) demonstrated a confirmed ORR of 58.3% in patients in China with previously treated HER2-mutant metastatic NSCLC, assessed by independent central review (ICR).
The safety profile of Enhertu in both trials was consistent with previous studies and did not present any new safety concerns.
Source: astrazeneca.com
