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AstraZeneca Imfinzi: Reduce the risk of death of Biliary Tract Cancer by 20%
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AstraZeneca Imfinzi Phase 3 Trials: Reduce the risk of death of Biliary Tract Cancer by 20%.
Reduce the risk of death by 20%! AstraZeneca’s Imfinzi Phase 3 Clinical Results Announced for Biliary Tract Cancer
AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy for the first-line treatment of patients with advanced biliary tract cancer (BTC) was associated with improved overall survival ( Statistically and clinically meaningful improvements in OS) and progression-free survival (PFS).
In a predefined interim analysis, among 685 patients who received AstraZeneca’s Imfinzi in combination with standard-of-care chemotherapy, there was a 20% lower risk of death compared with chemotherapy alone.
Median OS was 12.8 months in the Imfinzi plus chemotherapy arm compared to 11.5 months with chemotherapy.
An estimated 25 percent of patients in the Imfinzi-combination chemotherapy arm were still alive at two years, compared with 10 percent of those receiving chemotherapy.
In addition, the TOPAZ-1 trial results also showed that Imfinzi combined with chemotherapy reduced the risk of disease progression or death by 25%.
Median PFS was 7.2 months with combination therapy and 5.7 months with chemotherapy.
The objective response rate (ORR) was 26.7% for patients who received Imfinzi in combination with chemotherapy, compared with 18.7% for patients who received chemotherapy alone.
Advanced biliary tract cancer is a rare and aggressive cancer of the bile ducts and gallbladder that is diagnosed in approximately 210,000 people worldwide each year.
The prognosis for this type of patient is poor, with approximately 5 to 15 percent of BTC patients only surviving five years.
In terms of safety, Imfinzi in combination with chemotherapy did not increase the rate of discontinuation due to adverse events (AEs) compared with chemotherapy alone.
62.7% of patients who received Imfinzi in combination with chemotherapy, and 64.9% of patients who received chemotherapy alone experienced grade 3 or 4 treatment-related adverse events.
Treatment-related adverse events led to discontinuation in 8.9% of patients receiving the Imfinzi combination, compared with 11.4% of patients receiving chemotherapy.
Notably, TOPAZ-1 is the first phase 3 clinical trial to successfully show improved survival with an immune combination therapy in advanced BTC patients.
At the same time, Imfinzi combined with chemotherapy is also the first immune combination therapy with significantly better efficacy than standard of care.
Imfinzi is a human monoclonal antibody that targets programmed death ligand 1 (PD-L1), blocks the interaction of PD-L1 with PD-1 and CD80, and releases immune evasion strategies against tumors Suppression of immune responses.
Imfinzi has previously been approved as an immunotherapy for curative treatment following chemoradiation in patients with unresectable locally advanced (stage III) NSCLC.
In addition, Imfinzi is also approved for the treatment of extensive-stage small cell lung cancer (ES-SCLC) in many countries and regions around the world (including the United States, the entire European Union, China, Japan, etc.).
Imfinzi™ reduces risk of death in biliary tract cancer patients
AstraZeneca Imfinzi Phase 3 Trials: Reduce the risk of death of Biliary Tract Cancer by 20%
(source:internet, reference only)