Doublet immune checkpoint inhibitors

The global, open-label, phase III HIMALAYA trial (NCT03298451) included 1,171 patients with unresectable HCC and Child-Pugh class A liver disease who had not received prior systemic treatment. Patients were randomly assigned in a 1:1:1 ratio to receive STRIDE (a single dose of tremelimumab 300 mg IV) with durvalumab (1,500 mg IV) every 4 weeks, durvalumab monotherapy (1,500 mg IV every 4 weeks), or sorafenib (500 mg PO bid).[12]

The global, open-label, phase III HIMALAYA trial (NCT03298451) included 1,171 patients with unresectable HCC and Child-Pugh class A liver disease who had not received prior systemic treatment. Patients were randomly assigned in a 1:1:1 ratio to receive STRIDE (a single dose of tremelimumab 300 mg IV) with durvalumab (1,500 mg IV) every 4 weeks, durvalumab monotherapy (1,500 mg IV every 4 weeks), or sorafenib (500 mg PO bid).[12]

The median OS was 16.43 months (95% CI, 14.16–19.58) in the combination tremelimumab-durvalumab arm and 13.77 months (95% CI, 12.25–16.13) in the sorafenib arm (HR, 0.78; 96.02% CI, 0.65–0.93; P = .0035).[12][Level of evidence A1]

The global, open-label, phase III HIMALAYA trial (NCT03298451) included 1,171 patients with unresectable HCC and Child-Pugh class A liver disease who had not received prior systemic treatment. Patients were randomly assigned in a 1:1:1 ratio to receive STRIDE (a single dose of tremelimumab 300 mg IV) with durvalumab (1,500 mg IV) every 4 weeks, durvalumab monotherapy (1,500 mg IV every 4 weeks), or sorafenib (500 mg PO bid).[12]

The objective response rate was 20.1% for patients who received STRIDE and 5.1% for patients who received sorafenib.

The global, open-label, phase III HIMALAYA trial (NCT03298451) included 1,171 patients with unresectable HCC and Child-Pugh class A liver disease who had not received prior systemic treatment. Patients were randomly assigned in a 1:1:1 ratio to receive STRIDE (a single dose of tremelimumab 300 mg IV) with durvalumab (1,500 mg IV) every 4 weeks, durvalumab monotherapy (1,500 mg IV every 4 weeks), or sorafenib (500 mg PO bid).[12]

Grade 3 or higher treatment-related adverse events occurred in 50.5% of patients who received combination tremelimumab and durvalumab and 52.4% of patients who received sorafenib.