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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Wednesday, May 28, 2025
Shun Lu, MD, PhD, of the Shanghai Lung Cancer Center in Shanghai, China, and colleagues presented the updated phase 2 results from HORIZON-Lung, a multicenter, open-label, phase 1/2 study evaluating SHR-A1811 in HER2-altered non-small cell lung cancer at the 2025 AACR Annual Meeting. The updated analysis concluded that SHR-A1811 has shown continued clinical benefit, supporting the novel antibody-drug conjugate’s potential as a treatment option for patients with advanced HER2-mutant non-small cell lung cancer.
The study enrolled 94 patients with advanced NSCLC and centrally confirmed HER2 mutation, most commonly exon 20 insertions, who had been previously treated with platinum-based chemo and anti-PD-1/PD-L1 therapy. Patients were given 4.8 mg/kg of SHR-A1811 every three weeks intravenously. The median follow-up was 14.2 months. Objective response rate was 74.5% (95% CI 64.4-82.9), median duration of response was 9.8 months (95% CI 8.3-13.9), and median progression-free survival was 11.5 months (95% CI 9.7-15.2). While consistent benefits observed across baseline subgroups, median overall survival (OS) was not reached. The 12-month OS rate was 88.2% (95% CI 79.8-93.3).
Grade ≥3 treatment-related adverse effects occurred in 63 patients, or 67%, with ≥5% hematological toxicities. Interstitial lung disease occurred in 8 patients (8.5%; grade 1-2, n=7; grade 3, n=1). In total, treatment-related adverse effects lead to dose discontinuation in 2 patients and there were no treatment-related deaths. According to the study authors, this manageable safety profile, along with SHR-A1811’s efficacy, support it as a potential treatment option.
Disclosures: The study authors reported no conflicts of interest.
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