The MHLW has approved Imfinzi & Imjudo for liver, biliary tract & lung cancers. Imfinzi + Imjudo approved for unresectable HCC & NSCLC in combination with CT; Imfinzi for unresectable HCC as monotx. & for BTC
The approval was based on the results from the P-III trials (HIMALAYA & TOPAZ-1) published in NEJM & the P-III trial (POSEIDON) in the Journal of Clinical Oncology. In (HIMALAYA)/(POSEIDON)/(TOPAZ-1) trials, a reduction in risk of death (22%/23%/24% after 6.5mos. of follow-up), patients were alive in the combination therapy vs CT (31% vs 20% after 3yrs./33% vs 22% @2yrs./23.6% vs 11.5% @2yrs.), respectively
The safety profiles of the combination therapy & Imfinzi as monotx. were consistent with known profiles of each medicine with no new safety signals in all trials
Ref: AstraZeneca | Image: AstraZeneca
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