HealthDay News — Adding the immunotherapeutic agent durvalumab to standard chemotherapy improves survival in advanced biliary tract cancer, according to a study presented at the annual American Society of Clinical Oncology Gastrointestinal Cancers Symposium, held from January 20 to 22 in San Francisco.
Do-Youn Oh, MD, PhD, from the Seoul National University College of Medicine in South Korea, and colleagues randomly assigned 685 patients with previously untreated unresectable locally advanced, recurrent, or metastatic biliary tract cancer to receive either durvalumab or placebo in addition to gemcitabine and cisplatin [GemCis], followed by durvalumab or placebo until disease progression or unacceptable toxicity.
The researchers found that durvalumab plus GemCis significantly improved overall survival compared with placebo plus GemCis (hazard ratio, 0.80). There were also significant improvements in progression-free survival with durvalumab vs placebo (hazard ratio , 0.75). The objective response rate was 26.7% with durvalumab vs 18.7% with placebo. There were grade 3/4 treatment-related adverse events (TRAEs) in 62.7% of patients receiving durvalumab and 64.9% of those receiving placebo. Discontinuation of any study medication due to TRAEs occurred in 8.9% of patients receiving durvalumab and 11.4% of patients receiving placebo.
“We are hopeful that durvalumab plus gemcitabine and cisplatin will become a new standard of care for advanced biliary tract cancer,” Oh said in a statement. “Our first task at this time is boosting communication with patients and family members about the potential for this immunotherapy combination and what it may mean for their ongoing care.”
The study was funded by AstraZeneca, the manufacturer of durvalumab.