582P - Furmonertinib treatment in patients with EGFR-mutated non-small cell lung cancer and leptomeningeal metastases: A real-world study

Background

Leptomeningeal metastases (LM) is one of the most severe complications of NSCLC and always accompanied with poor prognosis. Furmonertinib (AST2818) is a pan-EGFR tyrosine kinase inhibitor with high brain penetration and wide therapeutic window. This study aims to evaluate the efficacy and safety of furmonertinib at 240mg/day in EGFR mutated NSCLC patients with leptomeningeal metastases (LM).

Methods

Patients were diagnosed as LM according to EANO-ESMO criteria. The primary endpoint was overall survival (OS), time to treatment discontinuation (TTD) and clinical response rate were secondary endpoints. Clinical response rate assessed with improvement of neurologic symptoms or signs and changes in the performance status. LM were assessed by investigator according to RANO-LM radiologic criteria.

Results

Between May 2021 and August 2023, 31 patients at Henan Cancer Hospital were enrolled. 26 (83.9%) patients received EGFR-TKI therapy prior to receive furmonertinib, 19 (61.3%) patients received at least 2 lines treatment, 21 (67.7%) patients received other 3rd generation EGFR-TKI therapy. The median age was 58 years (range:36-75), 23 (74.2%) were females. 21 (67.7%) patients with ECOG 3. 23 OS events had occurred at the data cut-off (1 August 2023), Median OS was 8.433 months (95%CI, 5.623 to 11.243) with 74.2% maturity. Median TTD was 7.633 months (95%CI, 3.688 to 11.579). The clinical response rate was 77.4%. The LM ORR and DCR assessed by investigator according to RANO-LM radiologic criteria were 54.2% and 95.8%, respectively. The safety profiles were consistent with previous reports for furmonertinib.

Conclusions

Furmonertinib 240mg/day has demonstrated clinically significant efficacy as first line and salvage therapy in patients with EGFR-mutant NSCLC and leptomeningeal metastases.

Clinical trial identification

ChiCTR2300072092.

Editorial acknowledgement

Legal entity responsible for the study

Qiming Wang.

Funding

Henan Province Health and Youth Subject Leader Training Project (No. [2020]60) The Excellent Young Talent Cultivation Project of Henan Health Science and Technology Innovation Talents (No. YXKC2020046). Henan International Joint Laboratory of drug resistance and reversal of targeted therapy for lung cancer (No. [2021]10).

Disclosure

All authors have declared no conflicts of interest.