FDA approves durvalumab to treat biliary tract cancer in combination with chemotherapy.
The FDA approved AstraZeneca’s Imfinzi (durvalumab) to treat adult patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin), making it the first immunotherapy combination approved for BTCs.
For the first time, patients in the United States with advanced BTC have an immunotherapy-based treatment option that “meaningfully extends survival and is well-tolerated,” said Dave Fredrickson, executive vice president of AstraZeneca’s Oncology Business Unit, in a news release.1
The Cholangiocarcinoma Foundation (CCF) also lauded the availability of the new treatment.
“As a 12-year survivor of Stage IV intrahepatic cholangiocarcinoma, I am excited to see a new standard of care for cholangiocarcinoma patients. This is the first improvement since 2010,” said Melinda Bachini, director of advocacy at CCF, in a blog post.2 “I hope we continue to see additional treatment options for our patient community and provide more hope for those in need.”
“The durvalumab approval is a big step forward and a significant change in trajectory for the treatment options available to this community. A new first-line treatment opens doors and increases opportunities for patients,” said Stacie Lindsey, founder and CEO of CCF.
FDA’s approval was based on the TOPAZ-1 Phase III trial, which was presented at the European Society of Medical Oncology (ESMO) Congress 2022 meeting in Paris, France, September 9-13.3 In an interim analysis of the trial, Imfinzi plus chemotherapy reduced the risk of death by 20% versus chemotherapy alone. An estimated 25% of patients treated with Imfinzi plus chemotherapy were still alive at 2 years compared to 10% treated with chemotherapy alone.
BTC is a group of rare and aggressive cancers in the bile ducts and gallbladder. Approximately 23,000 people in the United States are diagnosed with BTC each year and they have a poor prognosis, with approximately 5% to 15% of patients with BTC surviving 5 years, AstraZeneca said.
Based on data from the TOPAZ-1 trial, Imfinzi plus chemotherapy was added to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a Category 1 preferred regimen as 1st-line therapy for locally advanced or metastatic BTC in July.
1. IMFINZI® (durvalumab) plus chemotherapy approved in the US as the first immunotherapy regimen for patients with advanced biliary tract cancer. News release. AstraZeneca. September 5, 2022. Accessed September 12, 2022. https://www.businesswire.com/news/home/20220905005055/en/IMFINZI%C2%AE-durvalumab-Plus-Chemotherapy-Approved-in-the-US-as-the-First-Immunotherapy-Regimen-for-Patients-with-Advanced-Biliary-Tract-Cancer
2. FDA approval sets new standard of care for CCA. Blog post. The Cholangiocarcinoma Foundation (CCF). September 5, 2022. Accessed September 12, 2022. https://cholangiocarcinoma.org/new-standard-of-care-for-rare-cancer-with-fda-approval-of-imfinzi-applauded-by-cholangiocarcinoma-foundation/
3. Oh D, He AR, Qun S, et al. Updated overall survival (OS) from the phase III TOPAZ-1 study of durvalumab (D) or placebo (PBO) plus gemcitabine and cisplatin (+ GC) in patients (pts) with advanced biliary tract cancer (BTC). Presented at: European Society of Medical Oncology (ESMO) Congress 2022; September 10, 2022; Paris, France. Poster 13.