Express reduces the risk of death in patients with biliary tract cancer by 20%, and the blockbuster PD-L1 inhibitor combination has been granted priority review by the FDA

▎WuXi AppTec Content Team Editor Today, AstraZeneca announced that the FDA has granted a supplemental Biologics License Application (sBLA) for the anti-PD-L1 antibody durvalumab (Imfinzi).
Priority review designation for patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with standard chemotherapy
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The FDA is expected to respond in the third quarter of this year
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Advanced biliary tract cancer is a rare group of aggressive gastrointestinal cancers that usually develop in the bile ducts and gallbladder, with approximately 210,000 new diagnoses worldwide each year
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The early stages of the disease are often asymptomatic, so most new cases are diagnosed at an advanced stage when treatment options are limited
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The prognosis of patients is poor, with only about 5% to 15% of all patients living beyond 5 years
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Duvalumab is a humanized monoclonal antibody that can bind to PD-L1 protein, block its binding to PD-1 and CD80, and relieve immune evasion against tumors and relieve the inhibition of anti-cancer immune responses.

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In December 2020, durvalumab was granted orphan drug designation by the US FDA for the treatment of advanced biliary tract cancer
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In addition, durvalumab has also been approved in China for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) and non-small cell lung cancer (NSCLC)
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This sBLA is based on the results of an interim analysis of the Phase 3 clinical trial TOPAZ-1
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The trial results showed that durvalumab combined with chemotherapy reduced the risk of death by 20% compared with chemotherapy (HR=0.
80, 95% CI, 0.
66-0.
97, p=0.
021)
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Twenty-five percent of patients in the durvalumab group were still alive after two years, compared with 10% in the chemotherapy group
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In addition, durvalumab combination therapy reduced the risk of disease progression or death by 25% (HR=0.
75, 95% CI, 0.
64-0.
89, p=0.
001)
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Dr Susan Galbraith, Executive Vice President, Oncology R&D at AstraZeneca, said: "Patients with advanced biliary tract cancer have been challenged with poor prognosis and limited treatment options for many years
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Today's news highlights the urgency of bringing effective new treatments to these patients
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Working closely with the FDA to bring the first immunotherapy-based treatment option to these patients
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” Reference: [1] Imfinzi Plus Chemotherapy Granted Priority Review in the US for Patients With Locally Advanced or Metastatic Biliary Tract Cancer Based on TOPAZ-1 Phase III Trial.
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