Posted: Friday, September 30, 2022
Bruno Sangro, MD, PhD, of Clínica Universidad de Navarra and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Pamplona, Spain, and colleagues conducted a study to evaluate an immunotherapeutic infusion regimen consisting of a single, high priming dose of tremelimumab plus durvalumab (STRIDE) and monotherapy with durvalumab versus sorafenib in patients with unresectable hepatocellular carcinoma. The results of the multicenter, global phase III HIMALAYA trial, which were published in NEJM Evidence, showed favorable benefit-risk profiles for both the STRIDE regimen and durvalumab monotherapy.
“The STRIDE regimen demonstrated a statistically significant improvement in overall survival versus sorafenib,” the investigators commented. “Durvalumab monotherapy was noninferior to sorafenib for overall survival.”
A total of 1,171 systemic therapy–naive patients were randomly assigned to receive STRIDE (n = 393; tremelimumab: one dose of 300 mg; durvalumab: 1,500 mg every 4 weeks), durvalumab monotherapy (n = 389; 1,500 mg every 4 weeks), or sorafenib (n = 389; 400 mg twice daily). At data cutoff, the median durations of follow-up were 33.2, 32.6, and 32.2 months, respectively.
The median duration of overall survival was 16.4 months with STRIDE, 16.6 months with durvalumab monotherapy, and 13.8 months with sorafenib. The 36-month overall survival rates were 30.7%, 24.7%, and 20.2%, respectively. The overall survival hazard ratio for STRIDE versus sorafenib was 0.78 (P = .0035). Overall survival was noninferior with durvalumab monotherapy versus sorafenib (hazard ratio = 0.86). The median durations of progression-free survival did not seem to significantly differ among the treatment arms. The rate of grade 3 or 4 treatment-emergent adverse events was 50.5% with STRIDE, 37.1% with durvalumab monotherapy, and 52.4% with sorafenib.
“Findings from HIMALAYA suggest the addition of a single dose of tremelimumab is sufficient to add clinical activity to durvalumab alone,” the investigators concluded.
Disclosure: For full disclosures of the study authors, visit evidence.nejm.org.