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(Abstract)

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A phase II clinical trial was conducted to evaluate the efficacy and safety of combining anlotinib and osimertinib in patients with advanced non-small cell lung cancer (NSCLC) that had confirmed epidermal growth factor receptor (EGFR) T790M mutation after failure of prior EGFR tyrosine kinase inhibitors (TKIs). The study included 31 patients who received combination therapy, and the primary endpoint was progression-free survival (PFS). The results showed that the median PFS was 16.7 months, and the objective response rate (ORR) was 48.4%. The disease control rate (DCR) was 100%, indicating that the combination therapy was effective in controlling the disease. Adverse events were reported in 48.4% of patients, with hypertension and leucopenia being the most frequent. The study also explored potential biomarkers of resistance in circulating tumor DNA (ctDNA). Analysis of ctDNA showed that patients with undetectable ctDNA at a certain point during treatment had longer median PFS compared to those with detectable ctDNA. Changes in ctDNA were associated with treatment response, and patients who had clearance of EGFR mutations in ctDNA after 6 weeks of treatment had longer median PFS and higher ORR. Similar findings were observed for clearance of TP53 mutations after 6 weeks of treatment. Among patients with baseline T790M mutation, 86.4% had T790M loss after treatment. One patient had a C797S mutation, while other resistance mechanisms such as MET amplification, PIK3CA amplification, VEGFA amplification, and FGFR3 fusion were also identified. The study concluded that combining anlotinib and osimertinib could be an effective and safe treatment option for patients with EGFR T790M mutation who have failed prior EGFR-TKI therapy. Monitoring ctDNA could be useful for evaluating treatment response and exploring resistance mechanisms.

Asset Subtitle

Richeng Jiang

Meta Tag

Speaker Richeng Jiang

Topic Metastatic NSCLC: Targeted Therapy - EGFR/HER2

Keywords

phase II clinical trial

efficacy

safety

anlotinib

osimertinib

NSCLC

EGFR T790M mutation

PFS

ORR

ctDNA