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(Abstract)

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The NAUTIKA1 study presented preliminary results on the efficacy and safety of neoadjuvant alectinib in patients with stage IB-III ALK non-small cell lung cancer (NSCLC). Alectinib is a preferred first-line treatment for advanced ALK NSCLC, but its role in early-stage NSCLC is not well-defined. NAUTIKA1 is a phase II trial evaluating multiple therapies as neoadjuvant treatments for resectable NSCLC based on specific biomarker criteria.<br /><br />In this analysis, eight patients with ALK NSCLC were included. The patients received neoadjuvant alectinib for eight weeks followed by surgery and then up to four cycles of platinum-based chemotherapy. The primary endpoint was major pathological response (MPR), with secondary endpoints including pathological complete response (pCR) and objective response rate.<br /><br />The results showed that five out of seven patients achieved MPR, with two achieving pCR. There were no delays in surgery due to adverse events, and no major complications were reported. Six patients had R0 resections, and one patient had stable disease but did not proceed with resection due to the need for pneumonectomy. One patient was downstaged from stage IIIB to IIIA after neoadjuvant treatment. All patients reported at least one treatment-related adverse event, but most were grade 1 or 2. Only one patient had a grade 3 adverse event, which was resolved with dose reduction.<br /><br />Overall, the preliminary analysis suggests that neoadjuvant alectinib demonstrated major pathological response and was well-tolerated in patients with ALK NSCLC. Further analysis with a larger patient cohort will be presented at the conference.

Asset Subtitle

Jay Lee

Meta Tag

Speaker Jay Lee

Topic Local-Regional NSCLC: Novel Therapies & Trials

Keywords

NAUTIKA1 study

neoadjuvant alectinib

ALK non-small cell lung cancer

NSCLC

major pathological response

platinum-based chemotherapy

surgery

adverse events

R0 resections

treatment-related adverse event