Sie sind bereits registriert?
Loggen Sie sich mit Ihrem Universimed-Benutzerkonto ein:
Sie sind noch nicht registriert?
Registrieren Sie sich jetzt kostenlos auf universimed.com und erhalten Sie Zugang zu allen Artikeln, bewerten Sie Inhalte und speichern Sie interessante Beiträge in Ihrem persönlichen Bereich zum späteren Lesen. Ihre Registrierung ist für alle Unversimed-Portale gültig. (inkl. allgemeineplus.at & med-Diplom.at)
Nivolumab Not Superior to Sorafenib in Hepatocellular Cancer
The new standard of care first-line treatment for advanced hepatocellular cancer (HCC) is the combination of atezolizumab and bevacizumab, which replaced first-line sorafenib or lenvatinib. The combination of ipilimumab and nivolumab received regulatory approval for HCC based on phase 2 evaluation.
Investigators now report results of an international, industry-sponsored, open-label phase 3 trial comparing nivolumab to sorafenib in the first-line treatment of advanced HCC. Patients with Child-Pugh class A HCC who had not received prior systemic therapy were randomized to nivolumab 240 mg intravenously every 2 weeks or sorafenib 400 mg orally twice daily. Of 743 patients, median age was 65, most (85%) were men, most (60%) were treated in the U.S. and Europe, 31% were infected with hepatitis B and 23% with hepatitis C, and 58% had extrahepatic disease. PDL-1 score in tumor cells (TPS) was <1% in 82% of patients.
At a minimum follow up of 22.8 months, median overall survival did not differ significantly in the nivolumab and sorafenib arms (16.4 and 14.7 months; hazard ratio, 0.85; P=0.075). There was also no difference in median time to progression (3.8 and 3.9 months). The response rate was numerically but not significantly higher for nivolumab compared with sorafenib (16% and 7%); disease control rates were similar (55% and 58%). Outcomes trended better in the minority of patients who were TPS positive. No new safety signals were observed.
Nivolumab was not superior to sorafenib in the first-line treatment of HCC. Given the approval of the combination of nivolumab and ipilimumab for HCC, this could be considered an alternative in patients who are not candidates for combination therapy with atezolizumab/bevacizumab or for single-agent sorafenib or lenvatinib. Results of trials of other immunotherapy combination regimens in the first-line setting are pending.
Yau T et al.
Title: Nivolumab versus sorafenib in advanced hepatocellular carcinoma (CheckMate 459): A randomised, multicentre, open-label, phase 3 trial.
Source: Lancet Oncol 2021 Dec 13; [e-pub]. (Abstract/FREE Full Text)