AstraZeneca Reports the EC’s Approval of Imfinzi Regimen as Perioperative Treatment of NSCLC
Shots:
- The EC has approved perioperative Imfinzi regimen to treat resectable NSCLC adults at high risk of recurrence & no EGFR mutations or ALK rearrangements; MAA under PMDA review
- Approval was based on P-III (AEGEAN) trial assessing neoadj. Imfinzi (1500mg; Q3W × 4 cycles) + CT followed by adj. Imfinzi alone (Q4W × ~12 cycles) vs PBO in operable stage IIA-IIIB NSCLC pts (n=802), regardless of PD-L1 expression
- Trial showed 32% risk reduction in recurrence, progression, or death in interim EFS analysis (32% maturity), with final pCR analysis showing improved pCR rate (17.2% vs 4.3%). Interim OS data (35% maturity) presented at WCLC 2024 showed favorable trend, (mOS: not reached vs 53.2mos) & is still under assessment
Ref: AstraZeneca | Image: AstraZeneca
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
