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WCLC 2025 | NAUTIKA1: clinical outcomes of neoadjuvant alectinib in ALK+ NSCLC
Jay Lee, MD, University of California, Los Angeles, CA, discusses results from the Phase II NAUTIKA1 trial (NCT04302025) of neoadjuvant alectinib in resectable stage IB–IIIB ALK+ non-small cell lung cancer (NSCLC). Treatment with alectinib before surgery was associated with encouraging pathological regression and radiographic responses, alongside high rates of complete resections. Safety was manageable with no unexpected signals. This interview took place at 2025 World Conference on Lung Cancer (WCLC) in Barcelona, Spain.
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Transcript
So the NAUTIKA1 trial is a phase 2 study of perioperative alectinib, and patients receive two cycles of neoadjuvant therapy with alectinib followed by resection and an adjuvant standard of care chemotherapy followed by alectinib for up to two years. So the study outcomes revealed clinically meaningful pathologic regression with major pathologic response rates that were in the 60% range, about 61%, and pathologic complete response that was about 25%, and the objective response rate was about 63%...
So the NAUTIKA1 trial is a phase 2 study of perioperative alectinib, and patients receive two cycles of neoadjuvant therapy with alectinib followed by resection and an adjuvant standard of care chemotherapy followed by alectinib for up to two years. So the study outcomes revealed clinically meaningful pathologic regression with major pathologic response rates that were in the 60% range, about 61%, and pathologic complete response that was about 25%, and the objective response rate was about 63%. So these are very respectable and meaningful numbers following just two cycles of neoadjuvant alectinib. And the safety profile was quite excellent. There were no new safety signals and there were no intraoperative complications attributed to the alectinib.
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