Developing Research in HCC: AGITG and AstraZeneca Collaborative Meeting

In November this year, members of the AGITG leadership group held a collaborative meeting with AstraZeneca. The purpose of the meeting was to foster communication channels between the two groups, learn about AstraZeneca’s work in the area of Hepatocellular Carcinoma (HCC), and to investigate opportunities for development of investigator-initiated clinical trials by AGITG in HCC.

Developing research in HCC is a research priority for the AGITG. Our nine research priorities identify areas of greatest need and those that have the potential to significantly improve the knowledge base for clinical decision-making. To address this priority for the organisation, we are engaging with industry to spark ideas for research opportunities.

At the meeting, AstraZeneca presented their oncology research and development pipeline. Participants then engaged in a discussion about evidence gaps and future research opportunities in both HCC and gastric cancer. We look forward to progressing these ideas.

AstraZeneca currently has two trials in HCC that are open and recruiting with multiple sites across Australia. The coordinating investigator for both studies is AGITG member, Professor Stuart Roberts from the Alfred Hospital, Victoria. Prof Roberts is the Head of Hepatology and a consultant gastroenterologist at The Alfred.

Prof Roberts says, “The main aim of these studies is to determine whether adjuvant therapy with Durvalumab with or without Bevacizumab reduces the rate of recurrence of hepatocellular carcinoma following a treatment response with TACE (Emerald-1) or surgery or ablation (Emerald-2) as compared with placebo.”

The global studies have been slowly enrolling patients in Australia, in part because of the COVID-19 pandemic, but when complete, will provide vital information on the treatment of HCC. “These studies are very important as they will significantly help our understanding of whether immunotherapy can improve the outcomes of subjects who receive curative therapies or TACE by lowering the rate of recurrent disease after an initial complete response,” says Prof Roberts.

EMERALD-1: A randomised, double-blind, placebo-controlled, multicenter, global Phase III study to determine the efficacy and safety of transarterial chemoembolization (TACE) treatment in combination with durvalumab monotherapy or TACE given with durvalumab plus bevacizumab therapy compared to TACE therapy alone in patients with locoregional hepatocellular carcinoma not amenable to curative therapy. The study aims to enrol 600 patients with 193 study locations globally. Learn more about EMERALD-1

EMERALD-2: A Phase III, randomised, double-blind, placebo-controlled, multi-center, global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab monotherapy or placebo as adjuvant therapy. This study will be conducted in patients with HCC who are at high risk of recurrence after curative hepatic resection or ablation.The study aims to enrol 880 patients with 184 study locations globally. Learn more about EMERALD-2

We thank AstraZeneca for their continued support of the AGITG and GI Cancer Institute, and for their collaborative approach to help drive new research in HCC.