medwireNews: An updated analysis of the HIMALAYA trial indicates that the overall survival (OS) benefit conferred by tremelimumab plus durvalumab in patients with unresectable hepatocellular carcinoma (HCC) is maintained at the 4-year mark.
The OS rate at 48 months was 25.2% among participants who received the STRIDE (single tremelimumab regular-interval durvalumab) regimen and 15.1% among those given sorafenib, “representing an unprecedented survival rate in this disease setting,” say the researchers.
They add that no new serious treatment-related adverse events (AEs) were observed in the STRIDE group with longer follow-up.
The team writes in the Annals of Oncology that the “[r]esults continue to support the long-term benefits of STRIDE in a diverse population, reflective of [unresectable] HCC globally.”
In the open-label, phase 3 trial, 782 patients who had not received prior systemic therapy for unresectable disease were randomly assigned to receive either STRIDE – comprising a single dose of tremelimumab 300 mg plus durvalumab 1500 mg every 4 weeks – or sorafenib 400 mg twice daily. A further 389 patients received durvalumab monotherapy.
The primary analysis (median follow-up approximately 33 months) gave a significant hazard ratio (HR) for death of 0.78 in favor of STRIDE versus sorafenib, and it was the same in the updated analysis conducted at a median follow-up of around 48 months.
The median OS duration was 16.4 months in the STRIDE group and 13.8 months in the sorafenib group.
The OS benefit of the STRIDE regimen was seen “across clinically relevant subgroups,” such as by geographic region, ECOG performance status, etiology of liver disease, and baseline alpha-fetoprotein levels, note Bruno Sangro (Clínica Universidad de Navarra and CIBEREHD, Pamplona, Spain) and colleagues.
The updated analysis also confirmed the noninferiority of durvalumab monotherapy to sorafenib with respect to OS, they add.
The researchers highlight that “no late onset safety signals were identified” for the STRIDE regimen. The incidence of serious AEs related to treatment was similar to that seen in the primary analysis for all three study arms, with rates in the current analysis of 17.5% for STRIDE, 9.6% for sorafenib, and 8.5% for durvalumab alone.
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