SHANGHAI, May 31, 2022 /PRNewswire/ -- Recently, the Journal of Clinical Oncology (JCO, IF:44.544), an internationally renowned oncology journal, published an online paper on the AENEAS study of Ameile® (Aumolertinib Mesylate Tablets, an innovative drug developed by Hansoh Pharma), which was led by Professor Lu Shun of the Chest Hospital Affiliated to Shanghai Jiao Tong University. This is the first time that clinical data for a China-originated third-generation EGFR-TKI has been published in the official ASCO journal.
AENEAS is a randomized, controlled, phase III study of aumolertinib versus gefitinib for the first-line treatment of EGFR-sensitive mutation-positive locally advanced or metastatic NSCLC. The results of this study demonstrate the superior safety and efficacy profile of aumolertinib in the first-line treatment of EGFR-sensitive mutation-positive locally advanced or metastatic NSCLC.
Patients treated with first-line aumolertinib showed significantly longer PFS (mPFS: 19.3 months vs 9.9 months) and significantly longer DoR (mDoR: 18.1 months vs 8.3 months) compared to those treated with standard of care gefitinib, and aumolertinib demonstrated superior efficacy.
The median PFS benefit of aumolertinib was superior to gefitinib in all subgroups: 20.8 months vs 12.3 months in the 19del subgroup (HR 0.39, P<0.0001), and 13.4 months vs 8.3 months in the L858R subgroup (HR 0.60, P=0.0102); the PFS benefit was particularly pronounced in the brain metastasis subgroup, 15.3 months vs 8.2 months (HR 0.38, P<0.0001), i.e. a 62% reduction in the risk of disease progression or death, compared with 19.3 months vs 12.6 months (HR 0.51, P<0.0001) in the non brain metastasis group, suggesting a greater benefit of aumolertinib treatment for patients with brain metastases.
In terms of safety, the duration of treatment was longer in the aumolertinib group compared to the gefitinib group (median exposure: 463.5 days vs 254.0 days), but the incidence of rash, diarrhea, and elevated AST/ALT was lower, suggesting a safety advantage of aumolertinib as first-line therapy.
As the first randomized, controlled study of third-generation EGFR-TKI involving only Chinese patients, the AENEAS study more accurately reflects clinical response of Chinese patients. In December 2021, this indication was approved by the National Medical Products Administration as the second indication of Ameile®. Previously, the progress of the AENEAS study was first announced at the 2021 ASCO Annual Meeting and received widespread attention from international peers. The latest updates on the brain metastasis subgroup data will be released at the 2022 ASCO Annual Meeting.
Ameile® is the first China-originated third-generation EGFR-TKI that was developed in-house by Hansoh Pharma. Since its launch two years ago, Ameile® has been widely used in the clinic and has benefited more than 100,000 patients with NSCLC, winning praise from doctors and patients for its superior efficacy and safety profile. "The publication of the phase III clinical study data of Ameile® in JCO reflects the high recognition of Ameile® by the international academic community of oncology and is a major breakthrough of Chinese pharmaceutical innovation in the field of targeted lung cancer therapy." Dr. Lyu Aifeng, Executive Director of Hansoh Pharma remarked "As a leading innovation-driven pharmaceutical company in China, Hansoh Pharma will continue to accelerate the pace of scientific and technological innovation，so that patients can further benefit from China's medicine innovations all over the world."
About AENEAS
AENEAS is a multicenter, randomized, double-blind, controlled phase III study of aumolertinib versus gefitinib as first-line therapy for patients with EGFR-sensitive mutation-positive locally advanced or metastatic NSCLC, with a total of 400+ subjects enrolled. All the patients enrolled in this study are Chinese. It is the first randomized, controlled study of a third-generation EGFR-TKI drug as first-line therapy for Chinese lung cancer patients.
About Ameile® (Aumolertinib Mesylate Tablets)
Ameile® (Aumolertinib Mesylate Tablets) is China's first original third-generation EGFR-TKI innovative drug, which was independently developed by Hansoh Pharma, and also the world's first third-generation EGFR-TKI with median progression-free survival (mPFS) exceeding one year (for second-line treatment). It is highly effective in the treatment of adult patients with EGFR T790M mutation-positive locally advanced or metastatic NSCLC who have experienced disease progression on or after prior EGFR-TKI therapy. In March 2020, the first indication of Ameile® was approved for marketing, filling a void for third-generation EGFR-TKI in China; in December 2021, Ameile® was approved as first-line therapy for adult patients with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation-positive locally advanced or metastatic NSCLC, opening a new era of first-line treatment with the first China-originated third-generation EGFR-TKI. Aumolertinib was discovered by Hansoh Pharma, and Hansoh has partnered with EQRx on the development of aumolertinib outside of Greater China, with the goal of expanding access worldwide.
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