The phase 3 EMERALD-1 trial has met its primary end point and continues to assess durvalumab combined with transarterial chemoembolization and bevacizumab for the secondary end point of overall survival in patients with hepatocellular carcinoma.
The combination of durvalumab (Imfinzi) with transarterial chemoembolization (TACE) and bevacizumab (Avastin) led to a statistically significant and clinically meaningful improvement in progression-free survival in patients with hepatocellular carcinoma (HCC) eligible for embolization, meeting the primary end point of the phase 3 EMERALD-1 trial (NCT03778957).1
For safety, the safety profiles of durvalumab with TACE and bevacizumab were consistent with the known profile of each drug individually. No new safety findings were identified.
The trial continues to assess the secondary end point of overall survival (OS) and data plan to be presented at an upcoming medical meeting, as well as shared with regulatory authorities.
“Patients with liver cancer eligible for embolization experience high rates of progression or recurrence and do not have the opportunity for early intervention with effective systemic therapy. These results for durvalumab plus bevacizumab have the potential to reshape the treatment of this complex disease with a poor prognosis by showing for the first time that adding an immunotherapy combination to TACE significantly improves progression-free survival,” said Riccardo Lencioni, MD, professor and director of the cancer imaging program in the Department of Diagnostic and Interventional Radiology of Pisa University Hospital in Pisa, Italy, and principal investigator in the trial, in a press release.1
The randomized, double-blind, placebo-controlled, multicenter phase 3 EMERALD-1 trial is evaluating the efficacy and safety of durvalumab with TACE followed by durvalumab with or without bevacizumab in patients with HCC not amenable to curative therapy.2 The trial is randomizing 600 patients in a 1:1:1 fashion if they have 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 is 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, OS, health-related quality-of-life measures, and safety.
Durvalumab is approved in combination with chemotherapy for the treatment of locally advanced or metastatic biliary tract cancer and in combination with tremelimumab (Imjudo) in unresectable HCC based on findings from the phase 3 TOPAZ-1 (NCT03875235) and HIMALAYA trials (NCT03298451), respectively.1
Durvalumab is also the only approved immunotherapy in the curative-intent setting of unresectable, stage III non–small cell lung cancer for the treatment of patients whose disease has not progressed after chemoradiation therapy. This approval was based on the phase 3 PACIFIC trial (NCT02125461).
In addition to EMERALD-1, durvalumab is being further evaluated across multiple gastrointestinal cancer settings. The EMERALD-2 study (NCT03847428) is assessing durvalumab in combination with bevacizumab in adjuvant HCC, and the EMERALD-3 study (NCT05301842) is looking at durvalumab with tremelimumab, lenvatinib (Lenvima), and TACE for the treatment of patients with embolization-eligible HCC.