The Phase II DESTINY-Lung05 study results for Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate co-developed by AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568, OTCMKTS: DSNKY), were unveiled at the American Association for Cancer Research (AACR) 2024 annual meeting. The study reported an objective response rate (ORR) of 58.3% (95% CI: 46.1-69.8) among patients with HER2-mutated metastatic non-small cell lung cancer (NSCLC) in China. The 5.4 mg/kg dosage demonstrated clinically significant and durable efficacy, along with manageable safety profiles, aligning with findings from the DESTINY-Lung02 trial and supporting its application in the Chinese patient population.
Enhertu, which received its initial approval in the U.S. in December 2019, has since gained multiple indications, including HER2-positive and low-expression breast cancer, NSCLC, gastric/gastroesophageal junction adenocarcinoma, and HER2-positive tumors, establishing itself as the first tumor-agnostic HER2-directed cancer therapy globally.
In the DESTINY-Lung02 trial, over 60% of participants were of Asian descent, with 61.8% and 60.0% of Asian patients in the 5.4 mg/kg and 6.4 mg/kg cohorts, respectively. The results demonstrated a consistent benefit trend for the Asian population compared to the overall study group. This new data further solidifies Enhertu’s role as a standard treatment for advanced NSCLC with HER2 mutations. In February 2023, Enhertu was approved in China as a monotherapy for adult breast cancer patients with unresectable or metastatic HER2-positive disease who had previously received one or more anti-HER2 therapies. In July 2023, it was approved for adult breast cancer patients with unresectable or metastatic HER2 low expression (IHC 1+ or IHC 2+/ISH -) who had undergone at least one systemic treatment during metastatic disease or recurred within six months after completing adjuvant chemotherapy.- Flcube.com
