The 2022 ESMO (European Society for Medical Oncology) annual meeting will be held in Paris, France from September 9 to 13 in an "online + offline" form. Two related research abstracts of Hansoh Pharma's independently developed drug, Aumolertinib Mesilate Tablets (trade name: Ameile), have been selected to bring the latest scientific advances in the field of early and advanced lung cancer, respectively.
As the most prestigious and influential oncology conference in Europe, each ESMO annual meeting is attended by over 30,000 professionals and has become a vane for clinical experts and pharmaceutical companies in the field of oncology to track the latest clinical research progress, clinical practice and medical technology information worldwide.
Aumolertinib is China's first original third-generation EGFR-TKI 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 use), and has been repeatedly recognized by international authorities for its superior efficacy and safety profile. Recently, the results of the AENEAS trial on aumolertinib were published in the Journal of Clinical Oncology (Journal of Clinical Oncology (JCO), IF:44.544), an internationally renowned oncology journal, the latest subgroup data of brain metastases were announced at the ASCO (American Society of Clinical Oncology) annual meeting, and 21 abstracts were presented at the IASLC (International Association for the Study of Lung Cancer) WCLC (World Conference on Lung Cancer).
At this ESMO annual meeting, two aumolertinib-related research abstracts were selected, bringing indirect treatment comparisons of relative efficacy for aumolertinib VS osimertinib in EGFR-positive non-small cell lung cancer (NSCLC), as well as latest advances in the APPOINT study of adjuvant therapy for NSCLC.
Abstract No.: 1005P
Indirect treatment comparisons of relative efficacy for aumolertinib VS osimertinib in EGFR-positive non-small cell lung cancer (NSCLC)
Author: Sanjay Popat, The Royal Marsden Hospital
Introduction: This is an anchored indirect treatment comparison (ITC) of PFS, OS and any-grade treatment-emergent adverse events (AG-TEAE) between aumolertinib and osimertinib, using two analysis methods: a Bucher ITC, based on published aggregate data from the AENEAS (aumolertinib) and FLAURA (osimertinib) trials, and a simulated treatment comparison (STC), based on patient-level data from AENEAS and published aggregated data from FLAURA. In the STC, patients in AENEAS were regression-adjusted using the relationship between population characteristics and outcomes in AENEAS to predict the expected outcomes in the FLAURA trial population. Regression models were adjusted for identified potential effect modifiers and prognostic factors that were imbalanced across trials. For PFS, the primary efficacy endpoint, the Bucher HR for aumolertinib vs osimertinib was 1.00 (95% CI: 0.72 - 1.39), and the STC HR was 0.98 (95% CI: 0.68 - 1.42), suggesting no statistical difference. For OS, the Bucher HR suggests no statistical difference (1.02 [95% CI: 0.67 - 1.56]), while the STC HR shows a numerical difference favoring aumolertinib (0.73 [95% CI 0.44 - 1.22]). However, OS results from the AENEAS trial were not mature at the time of this analysis. For AG-TEAE, the Bucher OR was 0.65 (95% CI: 0.08 - 5.50).
Abstract No.: 948TiP
Efficacy and safety of almonertinib in the adjuvant treatment of resectable stage I non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-sensitizing mutations in solid and/or micropapillary components
Author: Baohui Han, The Shanghai Chest Hospital
Introduction: Pathological subtypes are prognostic indicators independent of TNM stage, and patients with micropapillary and solid components have poorer prognosis. Previous studies have found that the presence of a micropapillary component was significantly associated with worse recurrence-free survival in patients with stage I lung adenocarcinoma, and postoperative adjuvant chemotherapy can still bring benefit to those patients even with stage IA. Third-generation EGFR-TKI have recently shown striking benefit for postoperative adjuvant therapy in patients with EGFR-mutated NSCLC. At present, there is no systematic study on the efficacy and safety of third-generation EGFR-TKI in stage I NSCLC patients with high-risk recurrence factors, such as solid and micropapillary components. APPOINT is an ongoing multicenter study that will explore for the first time the efficacy and safety of aumolertinib as postoperative adjuvant therapy in patients with EGFR mutant stage I NSCLC with solid and/or micropapillary components ≥10%. The study intends to enroll 104 patients, of which 52 will receive almonertinib 110mg qd as adjuvant therapy (for a planned period of 3 years), and 52 will be closely followed up. The primary endpoint is the 2-year DFS rate, and the secondary endpoints include the 3-, 4-, and 5-year DFS rates, 5-year overall survival rate, safety and quality of life. Circulating tumor DNA will also be monitored during the study. Nine patients have been enrolled so far.
Details of selected abstracts for the 2022 ESMO annual meeting are available at: https://oncologypro.esmo.org/meeting-resources/esmo-congress
Posters with more information on aumolertinib-related studies will be released during the meeting, so please stay tuned!
