2023 World Conference on Lung Cancer (Posters)-P2.01. NAUTIKA1 Study: Preliminary Efficacy and Safety Data with Neoadjuvant Alectinib in Patients with Stage IB-III ALK+ NSCLC

P2.01. NAUTIKA1 Study: Preliminary Efficacy and Safety Data with Neoadjuvant Alectinib in Patients with Stage IB-III ALK+ NSCLC - PDF(Slides)

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This study, called NAUTIKA1, assessed the efficacy and safety of neoadjuvant alectinib in patients with stage IB-III ALK non-small cell lung cancer (NSCLC). The study enrolled patients with resectable NSCLC and ALK rearrangements. Neoadjuvant treatment consisted of alectinib followed by surgical resection. The primary endpoint was major pathological response (MPR), and secondary endpoints included radiographic response, pathological complete response (pCR), surgical outcomes, and safety.<br /><br />The results showed that neoadjuvant alectinib was associated with a good pathological response, with 66.7% of patients achieving MPR and 33.3% achieving pCR. Four patients had a partial response, while five had stable disease. Eight patients underwent complete resection without any major intraoperative complications. Adjuvant therapy was administered to eight patients after surgery.<br /><br />The study also reported on the safety of neoadjuvant alectinib. There were no surgery delays or treatment discontinuations due to adverse events. The most common treatment-related adverse events were constipation and increased blood creatine phosphokinase. No serious or fatal adverse events were reported.<br /><br />Overall, the study found that neoadjuvant alectinib was well-tolerated and associated with a favorable pathological response in patients with ALK non-small cell lung cancer. These findings support further investigation of alectinib in the neoadjuvant setting. The study is ongoing, with enrollment continuing and further data collection planned.

Asset Subtitle

Jay Lee

Meta Tag

Speaker Jay Lee

Topic Local-Regional NSCLC: Novel Therapies & Trials

Keywords

NAUTIKA1

efficacy

safety

neoadjuvant alectinib

stage IB-III

ALK non-small cell lung cancer

NSCLC

resectable NSCLC

ALK rearrangements

pathological response