2024 World Conference on Lung Cancer (WCLC) - Posters-P4.07D.02 Furmonertinib as Adjuvant Therapy in Postoperative EGFR-Mutated Stage IB-IIA NSCLC with High-Risk Pathological Factors

P4.07D.02 Furmonertinib as Adjuvant Therapy in Postoperative EGFR-Mutated Stage IB-IIA NSCLC with High-Risk Pathological Factors

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The ATHEM study investigates the efficacy and safety of Firmonertinib (previously known as Furmonertinib) as an adjuvant therapy for patients with stage IB-IIA EGFR-mutated non-small cell lung cancer (NSCLC) who have high-risk pathological factors, such as micropapillary (MP), solid (S), and spread through air spaces (STAS), following complete tumor resection. Firmonertinib is a third-generation EGFR tyrosine kinase inhibitor (TKI) with high brain penetration and activity across EGFR mutations, targeting EGFR sensitizing mutations and the Thr790Met mutation, while sparing wild-type EGFR.<br /><br />In this single-arm, open-label study (NCT05165355), 52 out of a planned 90 patients were enrolled as of March 2024, all possessing one or more high-risk pathological factors. They are receiving 80 mg of Firmonertinib daily as adjuvant therapy for three years. The primary endpoint is the disease-free survival (DFS) rate at two years, while secondary endpoints include overall survival (OS) and safety. <br /><br />Preliminary results with a median follow-up of 16.5 months showed no DFS events or radiographic recurrence among participants. In terms of safety, 28.8% of patients experienced treatment-related adverse events (TRAEs), predominantly Grade 1-2, such as rash (25%), diarrhea (7.7%), and mouth ulcers (1.9%). Only 1.9% of patients experienced a Grade 3 TRAE (diarrhea), which resolved with treatment continuation at the initial dose. There were no dose reductions, treatment discontinuations, or deaths related to TRAEs.<br /><br />The study is ongoing, but early findings demonstrate Firmonertinib's compelling efficacy and tolerable safety profile for these high-risk patients, marking it as a potentially valuable adjuvant therapy in their postoperative cancer care. Future data will further elucidate these initial results.

Asset Subtitle

Xiao-Long Li

Meta Tag

Speaker Xiao-Long Li

Topic Early-Stage NSCLC

Keywords

ATHEM study

Firmonertinib

EGFR-mutated NSCLC

adjuvant therapy

high-risk pathological factors

EGFR tyrosine kinase inhibitor

disease-free survival

treatment-related adverse events

third-generation EGFR TKI

NCT05165355