On May 29, the National Medical Products Administration (NMPA) approved the HER2-targeted antibody-drug conjugate (ADC) trastuzumab rezetecan (SHR-A1811) for marketing. It is indicated as a monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who harbor activating HER2 (ERBB2) mutations and have received at least one prior systemic therapy. This marks the first China-developed ADC approved for patients with HER2-mutated NSCLC, offering a new therapeutic option for this patient population.
The approval is based on the pivotal HORIZON-Lung study, led by Professor Lu Shun from Shanghai Chest Hospital.
The HORIZON-Lung study is a multicenter, open-label, Phase I/II clinical trial led by Professor Lu Shun’s team at Shanghai Chest Hospital. The Phase I portion aimed to determine the maximum tolerated dose (MTD) of trastuzumab rezetecan and evaluate its preliminary efficacy and safety in patients with HER2-mutated NSCLC. The study design included both dose-escalation and dose-expansion phases. In the Phase I part, trastuzumab rezetecan demonstrated preliminary anti-tumor activity and a favorable safety profile. The Phase II study was designed to further assess the efficacy and safety of trastuzumab rezetecan in patients with HER2-mutated NSCLC.
A total of 94 patients were ultimately enrolled in the study. The results showed that the objective response rate (ORR), as assessed by the Independent Review Committee (IRC), was 74.5%, with a disease control rate (DCR) of 98.9%. The median duration of response (DoR) was 9.8 months. Subgroup analyses indicated that the efficacy of trastuzumab rezetecan was consistent across different patient subgroups, regardless of prior anti-HER2 tyrosine kinase inhibitor (TKI) treatment or the presence of baseline brain metastases.
The IRC-assessed progression-free survival (PFS) showed a median PFS of 11.5 months, with a 12-month PFS rate of 48.6%. The investigator-assessed (INV) PFS was 12.5 months, with a 12-month PFS rate of 51.4%.
Overall survival (OS) data are not yet mature, with the median OS not yet reached and a 12-month OS rate of 88.2%.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
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Post time: Jun-04-2025