First immunotherapy regimen approved for advanced biliary tract cancer

The U.S. Food and Drug Administration has approved Imfinzi (durvalumab; AstraZeneca) for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin), according to a press release.

Approval is based on results from TOPAZ-1 Phase III trial results, which showed the combination of durvalumab plus chemotherapy reduced the risk of death by 20% versus chemotherapy alone. Approximately 25% of patients treated with durvalumab plus chemotherapy were still alive at 2 years compared to 10% treated with chemotherapy alone.

“This approval represents a major step forward for patients with advanced biliary tract cancer, who urgently need new, well-tolerated and effective treatment options after more than a decade of limited innovation. The combination of durvalumab and chemotherapy should become a new standard of care in this setting, having demonstrated significantly improved survival for these patients who have historically faced a poor prognosis,” said Aiwu Ruth He, MD, PhD, Associate Professor of Medicine, Leader of the GI Cancer Program, Georgetown Lombardi Comprehensive Cancer Center, Medstar Georgetown University Hospital, Washington DC, and a lead investigator in the TOPAZ-1 Phase III trial.

Read the full press release here.