AstraZeneca presents results from AEGEAN Phase III trial

Results from the AEGEAN Phase III trial showed that treatment with AstraZeneca’s IMFINZI in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery led to a statistically significant and clinically meaningful improvement in event-free survival versus neoadjuvant chemotherapy alone followed by surgery for patients with resectable early-stage non-small cell lung cancer. The combination of IMFINZI and neoadjuvant chemotherapy also demonstrated a statistically significant and meaningful improvement in pathologic complete response, a dual primary endpoint, compared to neoadjuvant chemotherapy alone, at a previously reported interim analysis. The final analysis was consistent with these previously announced positive results. In a planned interim analysis of EFS, patients treated with the IMFINZI-based regimen before and after surgery showed a 32% reduction in the risk of recurrence, progression events or death versus chemotherapy alone. In a final analysis of pCR, treatment with IMFINZI plus neoadjuvant chemotherapy before surgery resulted in a pCR rate of 17.2% versus 4.3% for patients treated with neoadjuvant chemotherapy alone. The trial will continue as planned to assess key secondary endpoints including disease-free survival and overall survival. IMFINZI was generally well tolerated and no new safety signals 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 compromise patients’ ability to complete surgery versus chemotherapy alone. Of patients treated with the IMFINZI-based regimen, 77.6% completed surgery compared to 76.7% of patients treated with chemotherapy alone. Grade 3/4 any-cause adverse events occurred in 42.3% of patients treated with the IMFINZI-based regimen versus 43.4% for chemotherapy alone.