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The #FDA has approved Tremelimumab plus Durvalumab for patients with unresectable #Hepatocellular Carcinoma. This approval was based on the results of the phase 3 HIMALAYA trial in which Tremelimumab (300 mg one-time single intravenous (IV) infusion) plus Durvalumab (1500 mg IV on the same day), followed by durvalumab 1500 mg IV every 4 weeks demonstrated a statistically significant and clinically meaningful improvement in OS compared to sorafenib (HR=0.78, p = 0.0035); median OS was 16.4 months versus 13.8 months.
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