Durvalumab Plus Chemo Reduced Risk of Death in Advanced BTC

Results from the TOPAZ-1 phase 3 trial of the immunotherapy agent durvalumab, in combination with standard-of-care chemotherapy, showed a significant and clinically meaningful improvement in both overall and progression-free survival among patients with advanced biliary tract cancer (BTC) over chemotherapy alone.

The combination therapy also demonstrated no increase in discontinuation of treatment due to adverse effects.

Because biliary tract cancer—rare and aggressive cancer of the bile ducts and gallbladder— frequently presents without clear symptoms, it is often diagnosed at an advanced stage when the prognosis is poor. Of the approximate 210,000 people worldwide diagnosed with BTC each year, approximately 5% to 15% survive for 5 years.

An interim analysis of patients treated with Imfinzi and standard-of-care chemotherapy showed  a 20% reduction in the risk of death vs chemotherapy alone. The median overall survival was 12.8 months vs 11.5 for chemotherapy. Approximately 25% of patients who received combined therapy were still alive at 2 years, vs 10% of those receiving chemotherapy alone.

The TOPAZ-1 trial also showed a 25% reduction in the risk of disease progression or death with durvalumab plus chemotherapy (HR, 0.75; 95% CI, 0.64-0.89; 2-sided p=0.001). Median progression-free survival among patients treated with the combined therapy was 7.2 months compared with 5.7 months among those who received chemotherapy alone. In addition, patients treated with durvalumab plus chemotherapy achieved an objective response rate (ORR) of 26.7% as compared to an ORR of 18.7% for patients treated with chemotherapy alone.

--Rebecca Mashaw

Imfinzi plus chemotherapy reduced risk of death by 20% in 1st-line advanced biliary tract cancer. News release. AstraZeneca; January 18, 2022. Accessed October 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