Abstract 86P
Background
Aumolertinib (HS-10296) is a novel, promising oral third-generation Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI), which has demonstrated efficacy in tumours harbouring sensitive EGFR mutations and T790M resistance mutation. Aumolertinib has also been shown to have efficacy in CNS metastasis. However, the efficacy and safety of aumolertinib as adjuvant therapy in postoperative patients remains unknown.
Methods
Patients who underwent radical lung cancer surgery with EGFR-sensitizing mutations were enrolled and received aumolertinib 110 mg daily, the medication time (6months-36months) depended on pathology stage and physical conditions. The disease-free survival (DFS), safety and tolerability were evaluated.
Results
The study retrospectively analyzed 66 patients with pathologically confirmed adenocarcinoma, EGFR mutation-positive (exon 19 deletion or L858R), stage I–III NSCLC. At the data cutoff, all patients have no symptoms of tumor recurrence, 25(37.9%) patients have been followed up for over 1 year. At 12 months, 100% patients were alive and disease-free, patients’conditions were evaluated by chest CT, PET-CT, abdominal ultrasound, cranial MRI and other auxiliary examination. None of these patients have central nervous system disease. During aumolertinib therapy, 34.8% of patients had adverse treatment-related adverse events of any grade, but there was no grade ≥3 adverse events occurred, rash (15/66, 22.7%), mouth ulcer (7/66, 10.6%) and diarrhea (5/66, 7.6%) were common adverse reactions. No patients withdrew from therapy because of adverse drug reactions. Interestingly, we found aumolertinib was also effective in multiple primary lung cancer, among patients (5/66, 7.6%) who have multiple malignant lesions (ground -glass opacity, and <3cm), with aumolertinib treatment, 2 patients had reduction in size of lesions, and the other patients had no change in size.
Conclusions
This is the first study to demonstrate that aumolertinib has preliminary efficacy and a tolerable safety profile in patients with completely resected stage Ⅰ-Ⅲ NSCLC harboring EGFR mutations. This study is still in progress and further analyses are undergoing to determine longer-term outcomes.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.