China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that its fifth indication filing for Ameile (almonertinib) has been accepted for review by the National Medical Products Administration (NMPA). The epidermal growth factor receptor (EGFR) inhibitor is now under review for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation when combined with pemetrexed and platinum-based chemotherapy.
Ameile’s Market Approval History and Impact
The home-grown third-generation EGFR-TKI received its initial market approval in China in March 2020 for use in T790M-mutated locally advanced or metastatic NSCLC following first-line EGFR-TKI treatment. In December 2021, it was approved for the first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 (L858R) replacement mutation-positive. Both indications are covered by the National Reimbursement Drug List (NRDL), enhancing patient access to this treatment.
Recent Indication Filings and Their Acceptance
The third and fourth indication filings for Ameile were accepted for review by the NMPA in July and August of this year, respectively. These filings include adjuvant therapy for EGFR exon 19 deletion or exon 21 (L858R) replacement mutation-positive NSCLC after tumor resection and irresectable locally advanced NSCLC with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation that does not show disease progression after platinum-containing radical radiotherapy and chemotherapy.
Positive Results from AENEAS2 Study Support Latest Filing
The latest filing is supported by positive results from the Phase III regulatory AENEAS2 study, which showed a more than 50% reduction in the risk of disease progression or death in patients receiving the Ameile combination treatment. The median progression-free survival was extended to over two years, with safety consistent with previous findings, demonstrating the potential benefits of Ameile in improving outcomes for patients with EGFR-mutated NSCLC.-Fineline Info & Tech
