Unpacking the EMERALD-1 Treatment Approach for HCC

Riccardo Lencioni, MD, professor in the department of radiology at the University of Pisa School of Medicine in Pisa, Italy, discusses how the new protocol from the phase 3 EMERALD-1 trial (NCT03778957) of durvalumab (Imfinzi), transarterial chemoembolization (TACE), and bevacizumab (Avastin) may be implemented in the community oncology setting for the treatment of hepatocellular carcinoma (HCC).

The randomized, double-blind, placebo-controlled, multicenter phase 3 EMERALD-1 trial is investigating a combined treatment approach for patients with unresectable hepatocellular carcinoma (HCC) who are eligible for TACE, a a minimally invasive, targeted procedure that aims to block the blood supply to the tumor and deliver chemotherapy directly to it.1 Patients in the study were randomly assigned to 1 of 3 groups. Enrollment in the phase 3 trial was open to patients who had confirmed HCC not amenable to curative therapy, a Child-Pugh score class A to B7, and an ECOG performance status of 0 or 1.

The primary end point of the study is progression-free survival (PFS) in arm A vs arm C by blinded independent radiology review using RECIST v1.1, and secondary end points include PFS for arm B vs arm C, overall survival, health-related quality-of-life measures, and safety. Lencioni presented updated findings from the study at the 2024 Gastrointestinal Cancers Symposium.

Transcription:

0:09 | The treatment regimen included 2 different parts. The first part is represented by TACE, which is combined with durvalumab. Then at and upon completion of the TACE cycles, patients were started on the combination of durvalumab and atezolizumab.

REFERENCE

Sangro B, Kudo M, Qin S, et al. A phase 3, randomized, double-blind, placebo-controlled study of transarterial chemoembolization combined with durvalumab or durvalumab plus bevacizumab therapy in patients with locoregional hepatocellular carcinoma: EMERALD-1. Ann Oncol.2020;31(suppl 3):S202-S203. doi:10.1016/j.annonc.2020.04.429