Shots:
- FDA has approved perioperative Imfinzi for adults with resectable, early-stage & locally advanced (Stages II, III, IVA) G/GEJ cancers, with submission reviewed under Project Orbis & based on P-III (MATTERHORN) trial; regulatory review is ongoing in the EU & Japan
- In the trial, Pts (n=948) received Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W × 2 cycles, then surgery followed by Imfinzi (2 cycles with FLOT CT + 10 cycles as monotx.) or PBO for Q4W × 12 cycles
- At interim analysis, the trial showed a 29% EFS improvement (mEFS not reached vs 32.8mos.), with EFS rates of 78.2% vs 74% at 1yr. & 67.4% vs 58.5% at 24mos. Final OS showed a 22% reduction in death risk, with 69% vs 62% alive at 3yrs. OS benefit continued to increase with longer follow-up, regardless of PD-L1 status
Ref: AstraZeneca | Image: AstraZeneca | Press Release
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