Additionally, the results also showed a 25% reduction in the risk of disease progression or death with durvalumab plus chemotherapy.
Positive results from the TOPAZ-1 phase 3 trial showed durvalumab (Imfinzi, AstraZeneca) in combination with standard-of-care chemotherapy demonstrated a statistically significant improvement in overall survival and progression-free survival versus chemotherapy alone as a first-line treatment for patients with advanced biliary tract cancer (BTC), according to an AstraZeneca press release.
Patients with BTC—a group of rare, aggressive cancers that occur in the bile ducts and gallbladder—have a poor prognosis with approximately 5% to 15% of all patients with BTC surviving 5 years, according to AstraZeneca.
“After minimal progress for more than a decade in advanced biliary tract cancer, the TOPAZ-1 results are a tremendous advance for our patients, showing a clear survival benefit for Imfinzi added to chemotherapy compared to standard of care with a remarkable safety profile,” said principal investigator Do-Youn Oh, MD, PhD, in the press release. “This combination will provide a desperately needed and potentially practice-changing new treatment option in a setting where the current prognosis is devastating.”
Patients treated with durvalumab in combination with standard-of-care chemotherapy experienced a 20% reduction in the risk of death versus chemotherapy alone, and an estimated 25% of patients were still alive at 2 years versus 10% for chemotherapy. Additionally, the results also showed a 25% reduction in the risk of disease progression or death with durvalumab plus chemotherapy. The patients who were treated with durvalumab plus chemotherapy achieved an objective response rate (ORR) of 26.7% versus an ORR of 18.7% for patients treated with chemotherapy alone.
Further, durvalumab plus chemotherapy did not increase the discontinuation rate due to adverse events (AEs) compared to chemotherapy alone. Grade 3 or 4 treatment-related AEs (TRAEs) were experienced by 62.7% of patients administered durvalumab and chemotherapy, and by 64.9% of patients administered chemotherapy alone. TRAEs led to a discontinuation of therapy in 8.9% of patients treated with the durvalumab combination versus 11.4% of patients receiving chemotherapy.
Imfinzi plus chemotherapy reduced risk of death by 20% in 1st-line advanced biliary tract cancer. AstraZeneca. January 18, 2022. Accessed January 19, 2022. https://www.astrazeneca.com/media-centre/press-releases/2022/imfinzi-plus-chemotherapy-reduced-risk-of-death-by-20-in-1st-line-advanced-biliary-tract-cancer.html