Ghassan K. Abou-Alfa, MD, Discusses Patient Population and Dosing of PD-L1/CTLA-4 Inhibitor Combo for HCC in HIMALAYA Trial

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

Transcript:

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.

Reference

1. Abou-Alfa G, Chan SL, Kudo M, et al. Phase 3 randomized, open-label, multicenter study of tremelimumab (T) and durvalumab (D) as first-line therapy in patients (pts) with unresectable hepatocellular carcinoma (uHCC): HIMALAYA. J Clin Oncol. 2022;40(suppl 4):379. doi: 10.1200/JCO.2022.40.4_suppl.379
2. Kelley RK, Sangro B, Harris W, et al. Safety, Efficacy, and pharmacodynamics of tremelimumab plus durvalumab for patients with unresectable hepatocellular carcinoma: Randomized expansion of a phase I/II study. J Clin Oncol. 2021;39(27):2991-3001. doi:10.1200/JCO.20.03555