AstraZeneca’s Imjudo (tremelimumab) + Imfinzi (durvalumab) Receive the US FDA’s Approval for Unresectable Liver Cancer
Shots:
- The approval was based on the P-III (HIMALAYA) trial evaluating Imjudo (300mg) + Imfinzi (1500mg, q4w) vs sorafenib in 1324 patients with HCC prior not treated with systemic therapy & not eligible for LRT at 181 centers across 16 countries
- The results showed that patients treated with the combination experienced a 22% reduction in risk of death, 31% vs 20% were still alive after 3yrs. vs the same duration of follow-up. The results were published in the NEJM with no increase in severe liver toxicity or bleeding risk
- The safety profiles were consistent with the known therapy profiles with no new safety signals. The regulatory applications are currently under review in the EU, Japan & multiple other countries for advanced liver cancer
Ref: AstraZeneca | Image: AstraZeneca’
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