Hansoh Pharma's Aumolertinib Plus Chemotherapy Shows Positive Phase III Results in EGFR-Mutated NSCLC

• Hansoh Pharmaceutical's Aumolertinib (Ameile) combined with chemotherapy met its primary endpoint in a Phase III trial (AENEAS2) for first-line treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer.
• The AENEAS2 trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients treated with Aumolertinib plus chemotherapy.
• Aumolertinib, a third-generation EGFR-TKI, has already been approved in China for NSCLC patients with T790M mutations and as a first-line treatment for EGFR exon 19 deletions or exon 21 (L858R) mutations.
• Detailed results from the AENEAS2 study will be presented at an upcoming medical conference and submitted to regulatory authorities for potential approval of the new treatment regimen.

Hansoh Pharmaceutical Group Company Limited announced that its Phase III registrational trial, AENEAS2, evaluating Aumolertinib (Ameile) in combination with chemotherapy as a first-line therapy for patients with locally advanced (Stage IIIB~IIIC) or metastatic (Stage IV) epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) has met its primary endpoint of progression-free survival (PFS). The study results indicate a statistically significant and clinically meaningful improvement in PFS for patients receiving the Aumolertinib and chemotherapy combination.

AENEAS2 Trial Results

The AENEAS2 trial is a Phase III registrational study designed to assess the efficacy and safety of Aumolertinib in combination with chemotherapy compared to chemotherapy alone in patients with advanced EGFR-mutated NSCLC. The trial's success in meeting its primary endpoint marks a significant step forward in the treatment of this patient population. Detailed findings from the study are slated for presentation at a future medical conference, and the data will be submitted to regulatory bodies for review and potential approval.

Aumolertinib: A Third-Generation EGFR-TKI

Aumolertinib (Ameile) is the first innovative third-generation EGFR-TKI drug wholly developed in China. It has already secured approval for various indications in NSCLC treatment.

In March 2020, Aumolertinib received approval for treating patients with locally advanced or metastatic NSCLC harboring the T790M mutation, who had previously progressed on or after EGFR-TKI therapy. This approval was successfully renewed in the 2022 National Reimbursement Drug List (NRDL) in January 2023. Furthermore, in December 2021, Aumolertinib was approved as a first-line treatment for adult patients with locally advanced or metastatic NSCLC whose tumors exhibit EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. This indication was also included in the 2022 NRDL in January 2023.

Further Development

In July 2024, the New Drug Application (NDA) for Aumolertinib as adjuvant therapy following tumor resection in NSCLC patients with EGFR exon 19 deletions or exon 21 L858R mutations was accepted by the National Medical Products Administration (NMPA). Additionally, in August 2024, the NDA for Aumolertinib in treating patients with locally advanced, unresectable NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations, who have not progressed following definitive platinum-based chemoradiotherapy, was also accepted by the NMPA. These regulatory submissions highlight the ongoing efforts to expand the clinical utility of Aumolertinib in NSCLC treatment.