2023 World Conference on Lung Cancer (Posters)-P2.09. A Phase II Trial of Anlotinib Plus Osimertinib in Advanced NSCLC with EGFR T790M Mutation After Failure of Prior EGFR TKIs

P2.09. A Phase II Trial of Anlotinib Plus Osimertinib in Advanced NSCLC with EGFR T790M Mutation After Failure of Prior EGFR TKIs - PDF(Slides)

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Pdf Summary

A Phase II clinical trial was conducted to evaluate the combination of anlotinib and osimertinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR T790M mutation after failure of prior EGFR-TKIs. The primary endpoint of the study was progression-free survival (PFS), and secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and adverse events (AEs). The trial enrolled 30 out of the planned 65 patients by July 2023.<br /><br />The results showed that the median PFS was 16.7 months, and the median OS was not reached. The ORR was 48.4%, and the DCR was 100%. Patients with undetectable ctDNA at Cycle 2 Day 21 had longer PFS compared to patients with detectable ctDNA. The clearance of EGFR mutations in ctDNA after 6 weeks of treatment was associated with longer PFS and higher ORR. However, patients with TP53 mutation-positive had shorter PFS and lower ORR. Among patients harboring baseline T790M mutation, most had T790M loss after treatment, indicating a potential resistance mechanism.<br /><br />The study concluded that the combination of osimertinib and anlotinib was an effective and safe treatment option for patients with EGFR T790M mutation who had failed prior EGFR-TKIs. Monitoring changes in ctDNA could help assess treatment response and explore mechanisms of acquired resistance to therapy.<br /><br />In terms of safety, the combination therapy showed promising results. Further follow-up and analysis are ongoing.

Asset Subtitle

Richeng Jiang

Meta Tag

Speaker Richeng Jiang

Topic Metastatic NSCLC: Targeted Therapy - EGFR/HER2

Keywords

Phase II clinical trial

anlotinib

osimertinib

advanced non-small cell lung cancer

NSCLC

EGFR T790M mutation

progression-free survival

objective response rate

disease control rate

overall survival