In October 2024, China granted its first conditional approval for trastuzumab deruxtecan, a targeted anti‑HER2 therapy, for patients with advanced non‑small‑cell lung cancer (NSCLC) that carry HER2‑activating mutations and have already received prior treatment. The 2025 CSCO Lung Cancer Guidelines quickly elevated the drug to a Level I recommendation for post‑line therapy in stage IV HER2‑mutant NSCLC. The approval rests on strong data from the DESTINY‑Lung02 (DL02) and its Chinese bridging study, DESTINY‑Lung05 (DL05). DL05 enrolled Chinese patients with metastatic non‑squamous NSCLC harboring HER2 exon 19/20 mutations. At a median follow‑up of 20.2 months, independent central review showed an objective response rate of 56.9 % (investigator review 59.7 %), disease‑control rates above 90 %, and a median progression‑free survival of roughly 9.8 months. Most strikingly, the median overall survival reached 21 months—far exceeding outcomes seen with conventional chemotherapy and making trastuzumab deruxtecan the first HER2‑targeted agent to demonstrate durable long‑term survival in this setting. The interview also highlighted sevabertinib, another promising HER2‑mutant NSCLC drug that has shown durable efficacy and manageable side effects. Its marketing application is under priority review by China’s National Medical Products Administration, with hopes for rapid approval. Together, these advances set a new survival benchmark and inject fresh optimism into the treatment landscape for HER2‑mutated lung cancer patients.
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