Durvalumab (Imfinzi) Plus Chemotherapy Demonstrates Superior Survival Benefit Over Standard Chemotherapy in First-Line Advanced Biliary Tract Cancer

On October 25, 2021, AstraZeneca announced that the blockbuster PD-L1 inhibitor durvalumab (trade name: Imfinzi), in combination with chemotherapy, met the primary endpoint in a Phase 3 clinical trial for the first-line treatment of patients with advanced biliary tract cancer (BTC). Compared with chemotherapy alone, the durvalumab combination provided a statistically and clinically significant overall survival (OS) benefit for patients. The press release noted that this is the first immunotherapy combination to demonstrate superior clinical outcomes compared to the standard of care in a global randomized clinical trial for this patient population.

Additionally, combination therapy significantly improved progression-free survival (PFS) and overall response rate in patients. In terms of safety, the combination regimen was well tolerated, with a safety profile comparable to that of the control group, and did not increase the discontinuation rate due to adverse events.

Advanced biliary tract cancer comprises a group of rare, aggressive gastrointestinal (GI) cancers that typically arise in the bile ducts and gallbladder, with approximately 210,000 new cases diagnosed globally each year. The disease is often asymptomatic in its early stages; consequently, most new cases are diagnosed at an advanced stage when treatment options are limited. Patients have a poor prognosis, with only approximately 5% to 15% of all patients surviving beyond five years.

Approximately 72% of tumors in patients with intrahepatic cholangiocarcinoma express PD-L1. Durvalumab is a humanized monoclonal antibody that binds to the PD-L1 protein, blocking its interaction with PD-1 and CD80, thereby counteracting tumor immune escape and reversing the suppression of antitumor immune responses. In December 2020, durvalumab was granted orphan drug designation by the U.S. FDA for the treatment of advanced biliary tract cancer. Additionally, durvalumab has been approved in China for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) and non-small cell lung cancer (NSCLC).

References:

[1] IMFINZI plus chemotherapy significantly improved overall survival in 1st-line advanced biliary tract cancer in TOPAZ-1 Phase III trial at interim analysis. Retrieved October 25, 2021, from https://www.astrazeneca.com/media-centre/press-releases/2021/Imfinzi-improved-survival-in-biliary-tract-cancer.html

(Original text abridged)

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