At the European Society for Medical Oncology (ESMO) 2024 conference, AstraZeneca (NASDAQ: AZN, LON: AZN) presented updated data from the HIMALAYA Phase III trial, demonstrating sustained and clinically meaningful overall survival (OS) benefits for patients with unresectable hepatocellular carcinoma (HCC) who had not previously received systemic therapy and for whom local therapy was not suitable. The combination of Imfinzi (durvalumab) and tremelimumab showed a significant improvement in OS over a 5-year period, marking the longest survival follow-up reported in a Phase III trial for advanced liver cancer immunotherapy to date.
The HIMALAYA study, a randomized, open-label, global multicenter Phase III clinical trial, compared the efficacy of Imfinzi monotherapy with the STRIDE regimen, which combines a single 300mg induction dose of tremelimumab with 1500mg of Imfinzi, followed by Imfinzi administered every four weeks, against the standard of care, the multi-kinase inhibitor sorafenib.
The trial results indicated that the combination therapy offered a survival advantage, reducing the risk of death by 24% over the 5-year follow-up. Approximately 19.6% of patients treated with the STRIDE regimen were alive after 5 years, compared to 9.4% of those treated with sorafenib.
Sarah Manes, Head of the Liver Cancer Program at the Global Liver Institute, stated, “Reaching the five-year survival milestone is clinically and emotionally significant for patients with advanced liver cancer and their families. We are encouraged by the progress made in improving treatment outcomes through new therapies, bringing new hope for long-term survival within our patient community.”
AstraZeneca, a pioneer in immunotherapy, has a comprehensive and diverse immuno-oncology portfolio and pipeline. The company is committed to reshaping cancer treatment with Imfinzi monotherapy and combination therapies with tremelimumab and other innovative immunotherapies and mechanisms, aiming to change patient outcomes.
The company is also exploring next-generation immunotherapies, such as bispecific antibodies, leveraging the distinct characteristics of the immune system to target cancer treatments, including cell therapies and T-cell engagers.
Susan Galbraith, Executive Vice President and Head of Oncology R&D at AstraZeneca, said, “The fact that nearly 20% of patients with advanced liver cancer are alive after 5 years with the STRIDE regimen is remarkable, historically only about 7% of patients survived 5 years. This is a significant step forward, setting a new benchmark for survival. It underscores our commitment to following patients over the long term to help shape the enduring clinical benefits of this innovative therapy.”- Flcube.com