Outcomes of Patients With Hepatocellular Carcinoma Treated With Durvalumab Plus Tremelimumab in Real-World Clinical Practice Who Met or Did Not Meet the Inclusion Criteria for the Phase 3 HIMALAYA Tri
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- #Real-World Study
- #Durvalumab-Tremelimumab
- #Hepatocellular Carcinoma
- A real-world study evaluated outcomes of 412 hepatocellular carcinoma (HCC) patients treated with durvalumab plus tremelimumab (Dur/Tre), comparing those who met the HIMALAYA trial criteria (92 patients) to those who did not (320 patients).
- Median progression-free survival (PFS) was longer in the HIMALAYA group (5.4 months) than the non-HIMALAYA group (3.0 months), with body mass index ≥25 kg/m² and portal vein invasion identified as independent predictors of PFS.
- Median overall survival (OS) was also longer in the HIMALAYA group (19.4 months) versus the non-HIMALAYA group (15.4 months), with ECOG performance status ≥1 and albumin-bilirubin (ALBI) grade ≥2 as independent determinants of OS.
- Adverse events included any-grade endocrine dysfunction in 14.1% of the HIMALAYA group and 6.6% of the non-HIMALAYA group, with higher grade ≥3 events in the HIMALAYA group.
- Subgroup analysis suggested that non-HIMALAYA patients with preserved hepatic function (ALBI grade 1) may achieve OS comparable to the HIMALAYA group, indicating favorable outcomes for patients meeting trial criteria or having good liver function.