PQA 07 - PQA 07 Gastrointestinal Cancer and Sarcoma/Cutaneous Tumors Poster Q&A
3076 - EMERALD-Y90: A Phase 2 Study to Evaluate Transarterial Radioembolization Followed by Durvalumab and Bevacizumab for the Treatment of Unresectable Hepatocellular Carcinoma Eligible for Embolization
R. Iyer1, A. Noonan2, B. Spieler3, S. White4, L. Kulik5, D. Underwood6, E. Heilbron6, B. Nguyen6, G. Wetherill7, and R. Salem8; 1Roswell Park Cancer Institute, Buffalo, NY, 2The Ohio State University Comprehensive Cancer Center, Columbus, OH, 3University of Miami, Miami, FL, 4Medical College of Wisconsin, Milwaukee, WI, 5Northwestern Memorial Hospital, Chicago, IL, 6AstraZeneca, Gaithersburg, MD, 7AstraZeneca, Cambridge, United Kingdom, 8Northwestern University, Chicago, IL
Purpose/Objective(s): In people with hepatocellular carcinomas (HCC), reported median progression-free survival (PFS) following locoregional therapy (LRT; TACE or TARE) is less than one year, highlighting a need for additional treatment options. The Phase 3 EMERALD-1 study (NCT03778957) has shown a statistically significant improvement in PFS with durvalumab + bevacizumab + TACE versus TACE alone in participants (pts) with unresectable HCC (uHCC) eligible for embolization. However, an unmet need still exists for evidence to support additional treatment options in settings where TARE is the preferred treatment modality. The EMERALD-Y90 study evaluates the efficacy and safety of TARE with durvalumab monotherapy (one cycle), followed by durvalumab + bevacizumab in pts with uHCC eligible for embolization; the hypothesis is that this regimen will prolong PFS.Materials/
Methods: EMERALD-Y90 (NCT06040099) is a Phase 2, single-arm study that will enroll approximately 100 pts aged =18 years with uHCC (Child-Pugh class A with ECOG PS 0–1) amenable to embolization who are ineligible for, or who have declined treatment with, resection and/or ablation, or liver transplant. Exclusion criteria include having received prior LRT (previous TACE, TARE, or SBRT associated with the curative setting more than 6 months prior to study is permitted, and radiofrequency ablation is permitted if the target lesion was not treated or had subsequently progressed), prior systemic therapy, or having evidence of extrahepatic spread or major portal vein invasion (Vp3/Vp4). Eligible pts will receive partition-based dosing of TARE using Y-90 glass microspheres. Following TARE, pts will receive a single dose of durvalumab 1500 mg followed by durvalumab 1120 mg + bevacizumab 15 mg/kg every three weeks until study completion, disease progression, unacceptable toxicity, or another discontinuation criterion is met.The primary endpoint is PFS (time from day of TARE until the date of disease progression as assessed by the investigator per mRECIST, or death due to any cause). Key secondary endpoints include safety and tolerability in terms of adverse events; and 6-, 12-, and 24-month PFS, objective response rate (proportion of pts with a confirmed complete response or partial response as assessed by the investigator per mRECIST), overall survival (time from start of TARE until death due to any cause), and duration of response (time from date of first documented response until date of progression as determined by the investigator per mRECIST, or death due to any cause). An early safety review is planned when at least 30 pts complete at least two cycles of durvalumab + bevacizumab. Study enrollment will take place at approximately 20 sites across the United States. Results: TBD. Conclusion: TBD.
