Hansoh Announces Phase III ARTS Trial Results of Aumolertinib as Adjuvant Therapy in EGFR-Mutated NSCLC at AACR 2025, Demonstrating 88.2% 2-Year DFS Rate

The 2025 AACR Annual Meeting is currently underway, and Hansoh Pharma has announced for the first timeAumetinib as II-IIIB Stage EGFR-Mutant Non-Small Cell Lung Cancer（NSCLC）Results of the Phase III ARTS Study on Adjuvant Therapy After Complete Tumor Resection in Patients(Registration Number: NCT04687241)。

Source: AACR Conference Official Website

ARTS ResearchThis is a randomized, double-blind, placebo-controlled multicenter Phase III clinical trial designed to evaluate the efficacy of Aumetinib versus placebo in treatment.Stage II-IIIB EGFR MutationNSCLC Patients(Regardless of whether adjuvant chemotherapy is received or not)Efficacy and safety.

The study enrolled a total of 214 Chinese patients who were randomly assigned to receive either amivantamab or placebo treatment. The primary endpoint was assessed by BICR.Disease-Free Survival（DFS）, secondary endpoints includeInvestigator-assessed DFS, Overall Survival（OS）AndSafety。The median follow-up time assessed by BICR was 27.6 months.

Results showIndicates, AumetinibGroupmDFS not reached as per BICR assessment, while the placebo group was 19.4 months.(HR 0.166, p<0.0001)。Aumetinib Group2-Year DFS Rate is 88.2%, and 40.6% in the placebo group. The DFS assessed by the investigators was consistent with the BICR evaluation results. At the data cutoff, the OS data were not yet mature.(Omutinib and Placebo OS Maturity: 2.8% vs. 3.8%)。

In terms of safety, the incidence rates of adverse events leading to dose interruption, dose reduction, and discontinuation in the Aumetinib and placebo groups were 12.3% vs. 17.8%, and 9.4%, respectively.vs. 1.9% and 0.9%vs. 0. No new safety risks observed.

In summary, for patients with stage II-IIIB EGFRm NSCLC who have undergone complete resection and received adjuvant therapy, amivantamab significantly improves DFS with statistical and clinical significance.

Ameitinib is the first domestically developed third-generationOn behalf ofEGFR TKI，Effectively inhibits sensitizing EGFR mutations（ex19del/L858R）And the T790M mutation associated with drug resistance. Currently, the product has been approved for three indications, which are:

• Second-line treatment for patients with locally advanced or metastatic NSCLC who have progressed after prior EGFR-TKI therapy and are T790M mutation-positive;

• First-line treatment with EGFR exon 19 deletion or exon 21（L858R）Adult patients with locally advanced or metastatic NSCLC who are positive for substitution mutations;

• Unresectable locally advanced EGFR exon 19 deletion or exon 21 without disease progression after platinum-based radical chemoradiotherapy（L858R）Treatment of NSCLC Patients with Substitution Mutations.

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