2023 World Conference on Lung Cancer (Posters)-P1.27. Efficacy and Safety of Aumolertinib as Adjuvant Therapy in Resectable Stage I NSCLC with High-grade Patterns and EGFR Mutations (APPOINT)

P1.27. Efficacy and Safety of Aumolertinib as Adjuvant Therapy in Resectable Stage I NSCLC with High-grade Patterns and EGFR Mutations (APPOINT) - PDF(Slides)

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The APPOINT study aims to explore the efficacy and safety of the third-generation EGFR-TKI aumolertinib as adjuvant therapy in stage I non-small cell lung cancer (NSCLC) patients with high-grade patterns. High-grade patterns, such as solid, micropapillary, or complex gland components, have been found to be prognostic indicators of poor prognosis independent of TNM stage. Previous studies have shown that adjuvant chemotherapy can benefit micropapillary predominant patients even with stage IA. Third-generation EGFR-TKI have also shown benefit in postoperative adjuvant therapy for patients with EGFR-mutated NSCLC. However, there has been no prospective study on the efficacy and safety of third-generation EGFR-TKI in stage I NSCLC patients with high-grade patterns.<br /><br />The APPOINT study is a prospective, multi-center, two-arm study that aims to enroll stage I NSCLC patients with solid, micropapillary, and/or complex gland components of at least 10%. After undergoing radical lung cancer surgery, the patients will receive oral aumolertinib 110 mg once daily as adjuvant therapy or undergo observation for 3 years. The study will also monitor circulating tumor DNA during the treatment period.<br /><br />The primary objective of the study is to assess the 2-year disease-free survival (DFS) rate of aumolertinib as adjuvant therapy compared to non-interventional observation in stage I NSCLC patients with high-grade patterns. Secondary objectives include assessing the 3-, 4-, and 5-year DFS rates and 5-year overall survival rates of aumolertinib as adjuvant therapy, as well as evaluating the safety and quality of life of the treatment.<br /><br />The study is currently ongoing, with the first patient enrolled in January 2022. As of April 2023, more than half of the patients have been recruited. The study is sponsored by Jiangsu Hansoh Pharmaceutical Group Co., Ltd.

Asset Subtitle

Baohui Han

Meta Tag

Speaker Baohui Han

Topic Early-Stage NSCLC: Innovation & New Technology

Keywords

APPOINT study

third-generation EGFR-TKI

aumolertinib

adjuvant therapy

stage I non-small cell lung cancer

NSCLC

high-grade patterns

prognostic indicators

TNM stage

adjuvant chemotherapy