Regulator recognizes Imfinzi indication for bile duct cancer


A new treatment method developed by domestic researchers and improved overall survival (OS) of biliary tract cancer patients in the primary treatment stage have won approval from the government regulatory body.


On Thursday, the Ministry of Food and Drug Safety approved the combination therapy of Imfinzi (durvalumab) and Gemcitabine/Cisplatin (GemCis) as the primary treatment for adults with locally progressive or metastatic biliary tract cancer.


On Thursday, the Ministry of Food and Drug Safety approved the combination of Imfinzi (durvalumab) and Gemcitabine/Cisplatin (GemCis) as the primary treatment for adults with locally progressive or metastatic biliary tract cancer.


Imfinzi + GemCis combination therapy is the first treatment that opened the door to immunotherapy in biliary tract cancer and the only therapy that has been shown to improve OS compared to GemCis single therapy which served as the standard treatment over the past twelve years.


It is all the more significant that national researchers have taken the lead in the successful conduct of the TOPAZ-1 study, the global Phase 3 clinical trial that served as the basis for the approval of the combination therapy Imfinzi + GemCis.


Oh Do-youn from Department of Hematology-Oncology at Seoul National University Hospital successfully completed TOPAZ-1 study based on positive result of investigator-led Phase 2 clinical trial on patients Koreans, rewriting the treatment paradigm for progressive bile duct cancer.


The TOPAZ-1 study is a multinational, randomized, double-blind, placebo-controlled Phase 2 study that combined Imfinzi with the existing standard treatment of GemCis and compared and evaluated it with a placebo combination therapy in 685 patients with progressive bile duct cancer.


Patient registration for this study was conducted in 17 countries, including the United States, Europe, and Latin America, and 55% of them were conducted in Asian countries, including Korea, Thailand, Japan and China.


According to research data updated in the New England Journal of Medicine (NEJM) Evidence in June, the hazard ratio (HR) of SG of the Imfinzi + GemCis group was 0.80 compared to the GemCis + placebo group, reducing the risk of death by approximately 20%. OS during the second year was 24.9% for the Imfinzi combination therapy group and 10.4% for the placebo combination therapy group.


The occupation-free survival (PFS) rate was 0.75, meaning that Imfinzi combination therapy reduced disease progression and risk of death by 25% compared to the placebo combination therapy group. Additionally, the objective response rate (ORR) of the Imfinzi-combo and placebo combo groups was 26.7% versus 18.7%.


On the other hand, the occurrence rates of abnormal reactions with 3-4 grades were similar in both groups – 75.7% versus 77.8%. The most commonly reported side effects were anemia (48.2%), neutropenia (31.7%) and nausea (40.2%), indicating that most side effects were caused by chemotherapy.


Based on the results of these studies, the combination therapy Imfinzi + GemCis obtained approval from the United States Food and Drug Administration in early September. It was the first approved primary treatment method for progressive bile duct cancer in 12 years since GemCis won FDA approval based on a Phase 3 clinical trial of the ABC- 02 in 2010.


The Korean government’s approval came two months after the US FDA’s approval, indicating that the clearance review process took place almost simultaneously in both countries. For this reason, the developers expect regulatory authorities to quickly provide insurance benefits for the Imfinzi + GemCis combination therapy.


As reasons for their optimistic prediction, the developers cited poor treatment records for bile duct cancer, few treatment options available in Korea, and strong domestic patient data based on phase 2 and 3 clinical trials. , including SG data, making driving easier. examination for reimbursement.


Additionally, international academic journals are likely to recognize the Imfinzi + GemCis combination therapy as the new standard therapy as the primary treatment for progressive bile duct cancer, adding to the grounds for reimbursement, industry executives said.

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