Posted: Thursday, June 8, 2023
According to George Lau, MBBS, MD, of the Humanity and Health Medical Group, Hong Kong, China, and colleagues, treatment with a single dose of the monoclonal antibodies tremelimumab plus durvalumab (STRIDE regimen) seemed to improve overall survival in patients with unresectable hepatocellular carcinoma and an immune-mediated adverse event. The findings of this exploratory analysis of the phase III HIMALAYA trial, which were presented during the 2023 American Society for Clinical Oncology (ASCO) Annual Meeting (Abstract 4004), appeared to be consistent with those of studies of other immune checkpoint inhibitors.
Patients who received at least one dose of the STRIDE regimen (n = 388; tremelimumab: one dose of 300 mg; durvalumab: 1,500 mg every 4 weeks) or durvalumab monotherapy (n = 388; 1,500 mg every 4 weeks) were included in the analysis. Any-grade immune-mediated adverse events, immune-mediated adverse events of grade 3 or 4, and immune-mediated adverse events leading to the discontinuation of therapy were reported in 35.8%, 12.6%, and 5.7% of patients treated with the STRIDE regimen and 16.5%, 6.4%, and 2.6% of those who received durvalumab monotherapy, respectively. A total of 20.1% of patients treated with STRIDE and 9.5% of those who received durvalumab monotherapy had immune-mediated adverse events requiring high-dose steroid treatment.
An improvement in the median duration of overall survival was seen with the STRIDE regimen in patients who experienced immune-mediated adverse events versus those who did not (hazard ratio [HR] = 0.73); the overall survival rates at 6, 12, and 24 months further exemplified a benefit in this population. According to the investigators, the association between immune-mediated adverse events and overall survival was less clear with durvalumab monotherapy (HR = 1.14). A landmark analysis of patients who did and did not experience immune-mediated adverse events within 6 months of receiving the STRIDE regimen (n = 307) or durvalumab monotherapy (n = 287) revealed overall survival hazard ratios of 0.65 and 1.39, respectively.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.