Ghassan K. Abou-Alfa, MD, examined the trial design of the phase 3 HIMALAYA trial of tremelimumab plus durvalumab for frontline hepatocellular carcinoma, with results presented at the 2022 Gastrointestinal Cancers Symposium.
CancerNetwork® spoke with Ghassan K. Abou-Alfa, MD, a medical oncologist at Memorial Sloan Kettering Comprehensive Cancer Center, at the 2022 Gastrointestinal Cancer Symposium about the patient population, dosing regimens, and eligibility criteria for enrollment in the phase 3 HIMALAYA study (NCT03298451), which looked at tremelimumab plus durvalumab (Imfinzi) vs durvalumab alone for unresectable hepatocellular carcinoma.1
The HIMALAYA study was a randomized, open-label, multicenter study covering patients from all over the world. It included patients like any other studies who are of appropriate performance status, good liver functionality with a Child-Pugh score of A. [They] randomized 1325 patients to 4 arms. The fourth arm of tremelimumab, anti–CTLA-4 at 75 mg given 4 times plus durvalumab, did not fare any better compared to durvalumab as a single agent in Study 22 [NCT02519348] that was already reported in [Journal of Clinical Oncology].2 As such, we stopped that arm and continued with 3 arms on the study, the first arm being a single dose of tremelimumab at 300 mg plus durvalumab. This was compared to sorafenib [Nexavar] looking for superiority of overall survival. In addition to that, we did look at single-agent durvalumab compared with sorafenib to look for noninferiority.