Hansoh Pharmaceutical's Ameile (Aumolertinib) Granted Third Indication in China for Unresectable Stage III NSCLC

On March 10, Hansoh Pharmaceutical Group Company Limited (hereinafter referred to as Hansoh Pharma) announced that a new indication for Almonertinib Mesylate Tablets (Almonertinib, trade name: Amelie) has been approved for marketing. It is intended for the treatment of patients with unresectable locally advanced epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation non-small cell lung cancer (NSCLC) who have not experienced disease progression after platinum-based radical chemoradiotherapy. This is the third indication approved for Amelie within five years of its market launch. Thus, Amelie becomes the only China-developed third-generation EGFR-TKI currently approved for maintenance therapy in stage III unresectable NSCLC patients following chemoradiotherapy.

This approval is mainly based on the POLESTAR (HS-10296-304) study. This is a randomized, double-blind, controlled, multi-center Phase III clinical study, led by Academician Jinming Yu of Shandong Provincial Cancer Hospital as the principal investigator. The study results were selected for the "Late Breaking Abstract (LBA)" list at the 2024 World Conference on Lung Cancer (WCLC) and presented in an oral report at the conference's Presidential Symposium.

The study results showed that Ameile reduced the risk of disease progression by more than 80%; the median progression-free survival (mPFS) was 30.4 months in patients treated with Ameile, compared to only 3.8 months in those receiving placebo. Moreover, consistent PFS benefits were observed across all predefined subgroups of Ameile, demonstrating comprehensive benefits across the patient population. Additionally, the objective response rate (ORR) assessed by BICR in the Ameile treatment group reached 57%, with the median duration of response (DoR) extending to 16.59 months. The median overall survival (OS) has not yet been reached, and the incidence of CNS lesions and distant metastases was lower. Patients in the Ameile treatment group after chemoradiotherapy showed good overall tolerability and manageability; among adverse events (AEs), the incidence of grade ≥3 radiation pneumonitis was 0%, and the incidence of interstitial pneumonia was also 0%.

To date, Amelior has had three indications approved for marketing, with the first two being renewed and included in the 2024 National Medical Insurance Catalogue in November 2024; additionally, marketing applications (NDA) for two other indications have been accepted.

Approved for Marketing: Second-line treatment for patients with locally advanced or metastatic NSCLC who have progressed after prior EGFR-TKI therapy and are T790M mutation-positive. Approval Date: March 2020.

Approved for marketing: First-line treatment for adult patients with locally advanced or metastatic NSCLC who are positive for EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. Approval date: December 2021.

Approved for Marketing: Maintenance treatment for patients with unresectable locally advanced non-small cell lung cancer (NSCLC) who have not experienced disease progression after platinum-based radical chemoradiotherapy, and who have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. Approval Date: March 2025.

NDA Accepted: Adjuvant treatment after surgery for adult patients with NSCLC who have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. Acceptance date: July 2024.

NDA Accepted: Targeted therapy combined with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. Acceptance date: November 2024.