Saeed discusses the phase 3 HIMALAYA trial results leading to recent FDA approval of durvalumab plus tremelimumab for unresectable hepatocellular carcinoma (uHCC). This combination regimen was informed by earlier phase 2 data showing improved survival with durvalumab plus tremelimumab over durvalumab alone.

In HIMALAYA, the durvalumab-tremelimumab arm demonstrated statistically significant improvement in median overall survival of 16 months compared with sorafenib, leading to its approval for HCC regardless of line of therapy. Recently presented 4-year overall survival data from HIMALAYA shows unprecedented long-term benefit, with 25% of patients on durvalumab-tremelimumab still alive at 4 years. This is a major improvement over the historical 5-year survival rate of less than 10% seen previously with other therapies.

Saeed notes these impressive long-term survival results set a new benchmark for outcomes with immunotherapy combinations in HCC. It provides confidence in a real survival advantage with this approach that can be conveyed to patients. Overall, he says this durvalumab-tremelimumab regimen represents an important step forward and a foundation to build upon for further progress.

Video synopsis is AI-generated and reviewed by OncLive® editorial staff.