Adjuvant Furmonertinib Shows Efficacy, Tolerability in EGFR+ NSCLC With High-Risk Factors

Furmonertinib (AST2818) had efficacy and an acceptable toxicity profile when utilized as adjuvant treatment in EGFR-mutated, stage IA2-IIIA non–small cell lung cancer with high-risk pathological factors who have undergone radical surgery, according to findings from a retrospective study presented at the 2023 ASCO Breakthrough Meeting.

All patients had been followed for at least 13 months, with 34.8% of patients followed for longer than 21 months. The median follow-up time was 18.5 months, and by the time of the data cutoff date of March 1, 2023, all patients were alive, and none experienced radiographic disease recurrence; this included 4.3% of those with EGFR exon 20 insertions.

Of the 69 evaluable patients, 34.8% experienced any-grade treatment-related adverse effects (TRAEs), with 2.9% of effects grade 3 or higher. The most common TRAEs included rash (17.4%), mouth ulcer (7.2%), diarrhea (7.2%), and elevated transaminase (5.8%). Only 2.9% of patients experienced grade 3 or higher TRAEs in the form of mouth ulcer (n = 1) and diarrhea (n = 1). One of the 2 patients ended up discontinuing treatment with furmonertinib.

“This is the first study to demonstrate that furmonertinib had good efficacy and a tolerable safety profile as adjuvant therapy in EGFR-mutated NSCLC patients with high-risk pathological factors who underwent radical lung cancer surgery,” Zheng Wu, of the Department of Surgery, The First Affiliated Hospital of Medical School of Zhejiang University, Hangzhou, Zhejiang, China, and colleagues, wrote in a poster on the data.

Prior studies have indicated that patients with NSCLC who have high-risk pathological features like micropapillary (MP), solid (S), spread through air spaces (STAS) and visceral pleural invasion (VPI) have poor prognosis. The third-generation EGFR TKI, furmonertinib, has previously been found to have activity in cancers harboring sensitive EGFR mutations and the T790M resistance mutation.

For the retrospective study presented at the meeting, investigators evaluated the safety and efficacy of the agent when used as adjuvant treatment in patients with EGFR mutations and MP/S/STAS/VPI who have undergone radical surgery for their disease. Participants were given furmonertinib orally at a daily dose of 80 mg. The duration of adjuvant therapy was based on patients’ physical condition and pathologic stage; it ranged from 6 to 36 months. Patients were assessed for disease-free survival, safety, and tolerability.

All 69 patients had at least 1 high-risk pathological factor. When broken down, 63.8% had MP, 20.3% had S, 14.5% had STAS, and 47.8% had VPI. Of those with stage IA2-IB disease (n = 44), 43.5% had MP, 10.1% had S, 7.2% had STAS, and 17.4% had VPI. In those with stage IIA-IIB disease (n = 17), these rates were 14.5%, 4.3%, 1.4%, and 23.2%, respectively. In those with stage IIIA disease (n = 8), these rates were 5.8%, 5.8%, 5.8%, and 7.2%, respectively.

“We will continue to include cases from more clinical centers and conduct longer follow-up to obtain long-term overall survival and DFS results,” the study authors concluded.

Reference

Wu Z, Zhang Q, Ke L, et al. Furmonertinib as adjuvant therapy in postoperative EGFR-mutated stage IA2-IIIA non-small cell lung cancer (NSCLC) with high-risk pathological factors. Presented at: 2023 ASCO Breakthrough Meeting; August 3-5, 2023; Yokohama, Japan. Abstract 150.