Imfinzi plus chemotherapy approved in the EU as first immunotherapy regimen for patients with advanced biliary tract cancer.- AstraZeneca

The approval by the European Commission was based on the primary results from the TOPAZ-1 Phase III trial published in the New England Journal of Medicine Evidence, and on the updated results presented at the European Society for Medical Oncology Congress 2022. The approval follows the recommendation by The Committee for Medicinal Products for Human Use of the European Medicines Agency in November 2022.

At the interim analysis, Imfinzi plus chemotherapy reduced the risk of death by 20% versus chemotherapy alone (based on a hazard ratio [HR] of 0.80; 95% confidence interval [CI] 0.66-0.97; p=0.021). Updated results from TOPAZ-1 after an additional 6.5 months of follow-up showed a 24% reduction in the risk of death versus chemotherapy alone (HR 0.76; 95% CI, 0.64-0.91), with more than two times as many patients treated with Imfinzi plus chemotherapy estimated to be alive at two years versus chemotherapy alone (23.6% versus 11.5%). Updated median overall survival (OS) was 12.9 months versus 11.3 with chemotherapy.

See- Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer"-Do-Youn Oh, M.D., Ph.D., Aiwu Ruth He, M.D., Ph.D., Shukui Qin, M.D., Li-Tzong Chen, M.D., Ph.D. Takuji Okusaka, M.D., Ph.D,et.al.., for the TOPAZ-1 Investigators:Published June 1, 2022. NEJM Evid 2022; 1 (8). DOI:https://doi.org/10.1056/EVIDoa2200015.