Durvalumab regimen extends OS in advanced biliary tract cancer
The addition of durvalumab to standard first-line chemotherapy extended survival among patients with advanced biliary tract cancer, according to topline data released by the agent’s manufacturer.
The combination prolonged OS and PFS and also induced a higher overall response rate, interim analysis results of the randomized phase 3 TOPAZ-1 trial showed.
Durvalumab (Imfinzi, AstraZeneca), a human monoclonal antibody that binds to PD-L1, is approved in the United States for treatment of certain patients with lung cancer.
The double-blind, multicenter TOPAZ-1 trial included 685 patients with unresectable advanced or metastatic biliary tract cancer, including intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancer.
Researchers randomly assigned patients to first-line gemcitabine and cisplatin plus either durvalumab or placebo.
Interim analysis results showed the durvalumab regimen extended OS — the study’s primary endpoint — and also conferred benefit with regard to PFS and ORR, both of which served as secondary endpoints.
The durvalumab-chemotherapy combination appeared well-tolerated and did not result in a higher treatment discontinuation rate compared with chemotherapy alone.
Complete data will be submitted for presentation at a medical meeting.
“Patients with advanced biliary tract cancer are in dire need of new treatments as progress in the first-line setting has remained largely stagnant for more than 10 years,” Do-Youn Oh, MD, PhD, principal investigator of the TOPAZ-1 trial and professor in the division of medical oncology at Seoul National University Hospital and Seoul National University College of Medicine, said in an AstraZeneca-issued press release. “TOPAZ-1 is the first phase 3 trial to show that adding an immunotherapy to standard chemotherapy delivers a meaningful overall survival benefit for patients in this setting. [These] exciting results are a major step forward in treating this disease and represent new hope for our patients.”
