AstraZeneca announces AEGEAN trial demonstrated statistical significance

Results from a planned interim analysis of the AEGEAN Phase III, placebo-controlled trial showed that treatment with AstraZeneca’s Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery demonstrated a statistically significant and clinically meaningful improvement in event-free survival, or EFS, versus neoadjuvant chemotherapy alone followed by surgery for patients with resectable early-stage, or IIA-IIIB, non-small cell lung cancer, or NSCLC. Results from the final pathologic complete response, or pCR, and major pathologic response, or mPR, analyses were consistent with previously announced results. The trial will continue as planned to assess key secondary endpoints including disease-free survival, or DFS, and overall survival. Imfinzi was well tolerated and no new safety concerns were observed in the neoadjuvant and adjuvant settings. Further, adding Imfinzi to neoadjuvant chemotherapy was consistent with the known profile for this combination and did not increase complications or adverse events, or compromise patients’ ability to undergo surgery versus chemotherapy alone.