Results from the HIMALAYA Clinical Trial for Hepatocellular Carcinoma

Описание: Shubh Goel, VP, Head of Immuno-Oncology and GI Tumors Franchise for US Oncology at AstraZeneca, discusses results from the HIMALAYA clinical trial for hepatocellular carcinoma (HCC).

HCC is a rare liver carcinoma characterized by nodules occurring within the liver. These nodules are composed of neoplastic epithelial cells with hepatocellular differentiation. The vast majority of tumors are associated with chronic liver disease (such as hepatitis B or C, or steatohepatitis) or exposure to a variety of exogenous agents. Patients may present with signs and symptoms related to the tumor, as well as to the underlying condition. Common manifestations include right upper quadrant abdominal pain, weight loss, hepatosplenomegaly, jaundice, and ascites. Symptomatic tumors generally have poor prognosis.

The HIMALAYA study was a phase 3 randomized, open-label, multicenter, global clinical trial testing the efficacy of the STRIDE regimen (Imfinzi [durvalumab] and Imjudo [trermelimumab-actl]) versus sorafenib, a standard-of-care multi-kinase inhibitor. 1,324 patients with unresectable, advanced HCC who had no prior systemic therapy and were not eligible for localized therapy were involved. The primary endpoint was overall survival for the STRIDE regimen versus sorafenib.

Durvalumab is a human monoclonal antibody that binds to the PD-L1 protein and inhibits the interaction of PD-L1 and CD80.

Tremelimumab is a human monoclonal antibody that targets and blocks cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) activity. This leads to T-cell activation which primes the immune response to cancer and fosters cancer cell death.

Durvalumab plus tremelimumab had an observed sustained overall survival benefit in advanced disease, with one in five patients alive at five years. This combination of therapies reduced the risk of death by 24% compared to sorafenib. About 19.6% of the STRIDE patients were alive at five years versus 9.4% of those treated with sorafenib. In an additional subgroup analysis of patients who achieved disease control, 28.7% of STRIDE patients were alive after five years versus 12.7% of sorafenib patients.

Chapters:
HCC Overview 00:00
Current Management 2:18
HIMALAYA Clinical Trial 3:12
Implications for Practitioners 5:33