AstraZeneca’s Imfinzi (durvalumab) + Imjudo (tremelimumab) Receives EU Approval for Advanced Liver and Non-Small Cell Lung Cancer
Shots:
- The approval was based on the P-III trial (HIMALAYA) evaluating Imjudo (300mg) + Imfinzi (1500mg, q4w) vs sorafenib in 1324 patients with HCC & P-III (POSEIDON) trial of Imfinzi + Imjudo & CT vs CT alone in 1013 patients with metastatic NSCLC
- In (HIMALAYA) & (POSEIDON) trials published in the NEJM & Journal of Clinical Oncology, 22% & 23% reduction in risk of death, m-OS (16.4 vs 13.8mos.) & (14.0 vs 11.7mos.), patients were alive (31% vs 20%) @3yrs. & (33% vs 22%) @2yrs. & no new safety signals were seen
- In (POSEIDON) trial, 28% reduction in risk of disease progression or death, m-PFS (6.2 vs 4.8mos.) & updated results @4yrs. of follow-up showed a sustained survival benefit, 25% reduction in risk of death, m-OS (14 vs 11.7mos.), 25% vs 13.6% were alive @3yr.
Ref: AstraZeneca | Image: AstraZeneca
Related Post:- AstraZeneca’s Imfinzi (durvalumab) + Imjudo (tremelimumab) Receive MHLW’s Approval for Advanced Liver and Non-Small Cell Lung Cancers
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