Single center pilot study of neoadjuvant and adjuvant osimertinib in stage IA-IIIA, EGFR-mutant non-small cell lung cancer

Standard-of-care for resected stage IB-IIIA non-small cell lung cancer (NSCLC) with EGFR-mutation is resection followed by three years of adjuvant osimertinib. The role of neoadjuvant osimertinib is not yet clear. The pilot NORA study, at Yonsei University (Seoul, South Korea) evaluated two cycles of neoadjuvant osimertinib followed by resection and three years of adjuvant osimertinib for EGFR-mutant stage IA-IIIA NSCLC. The primary endpoint was objective response rate after 2 neoadjuvant treatment. This ORR was 44%, all partial responses, not reaching the primary end point, whereas all other patients had stable disease. None of the patients received adjuvant chemotherapy. The median disease-free survival was not reached after a median follow-up of 31 months (range 13.8-38.6). There were no grade 3 adverse events during neoadjuvant treatment. The authors conclude that the study did not meet the primary endpoint of ORR, but that neoadjuvant osimertinib is a feasible approach with a manageable safety profile in resectable EGFR-mutant NSCLC.