Durvalumab/Tremelimumab Reinforced as Standard of Care for Unresectable HCC

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The clinically meaningful overall survival (OS) benefit observed with durvalumab (Imfinzi) plus tremelimumab (Imjudo) in patients with unresectable hepatocellular carcinoma (HCC) naïve to systemic therapy and who are not eligible for local therapy has been sustained at 4 years, according to updated results from the phase 3 HIMALAYA trial (NCT03298451).¹

The updated findings, which were presented during the European Society of Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer, showed a 22% reduction in the risk of death in patients who received durvalumab plus tremelimumab (STRIDE regimen) compared with those treated with sorafenib (Nexavar) for a hazard ratio (HR) of 0.78 (95% CI, 0.67-0.98; P =.0037). The median OS observed at the 4-year analysis was 16.4 months (14.2-19.6 months) with the STRIDE combination compared with 13.8 months (12.3-16.1 months) with sorafenib.

“Historically, only 7% of patients with advanced liver cancer have survived 5 years, making the HIMALAYA long-term survival data especially meaningful. One in 4 patients treated with the STRIDE regimen were still alive at 4 years, reinforcing this novel regimen as a standard of care in this setting,” said Bruno Sangro, MD, PhD, director, liver unit and professor, internal medicine, Clínica Universidad de Navarra, in a press release.

The OS data had reached 78% maturity by the time of the ESMO World Congress on Gastrointestinal Cancer presentation. Investigators estimated that the 36-month OS rate would be 30.7% among patients treated with the STRIDE regimen vs 19.8% for those who received sorafenib. At 48-months, the estimated OS rates were 25.2% vs 15.1%, respectively.

Data from an ad hoc exploratory analysis revealed that outcomes for patients treated with the STRIDE regimen compared with sorafenib were consistent in 100% of the clinically relevant subgroup, including patients who survived for at least 3 years. The benefit of the experimental combination was irrespective of comorbid conditions and baseline characteristics.

In terms of safety, the STRIDE regimen displayed a safety profile consistent with its history. No new safety signals were observed with durvalumab or tremelimumab. In the STRIDE arm, serious treatment-related adverse events (TRAEs) occurred in 17.5% of patients compared with 9.6% in the sorafenib arm. However, no TRAEs occurred after the primary analysis in patients treated with the STRIDE regimen.

“The remarkable 4-year survival benefit shown with [durvalumab and tremelimumab] in this advanced liver cancer setting supports the use of the STRIDE regimen to treat a broad, eligible patient population globally. These latest results from HIMALAYA are part of a series of clinical trials aiming to deliver innovative treatments for patients at different stages of liver cancer,” said Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, in a press release.

_REFERENCES:

_{Imfinzi plus Imjudo demonstrated sustained overall survival benefit in advanced liver cancer with an unprecedented one in four patients alive at four years in HIMALAYA phase III trial. News release. AstraZeneca. June 29, 2023. Accessed June 30, 2023. https://tinyurl.com/2ea555wy}