Imfinzi

Imfinzi (durvalumab) is a drug reviewed under BLA 761069Orig1s000. The review documents indicate its use in 2nd-line post-platinum urothelial carcinoma (UC) patients. The efficacy of Imfinzi was assessed in a study population of 182 2nd-line UC patients, with a durvalumab dose of 10 mg/kg. The overall response rate (ORR) in the overall study population (excluding 10 patients) was 16.9%, while the ORR as per investigator assessment was 19.2%. The historical ORR to exclude was 10%, and the expected ORR range for PD-L1-high status was 17%-33%.

Safety findings indicate that 96% of patients experienced Grade 1-4 Adverse Reactions, with 46% experiencing Grade 3-4 Adverse Reactions. Total immune-mediated adverse events (imAEs), including endocrine events, in 2nd-line Post Platinum UC patients were 15. Diarrhea (Grade 1-4) was observed in 13% of patients. There were 46 total deaths, with 23 deaths occurring within 30 days of the last dose. Deaths attributed to disease progression were 16, while 7 were attributed to other/unknown/toxicity. Durvalumab-related toxic deaths were reported as 2 by the Applicant and 5 by the Reviewer.

Regulatory information notes that 1037 investigators were identified, with no sponsor employees among them and no investigators having disclosable financial interests/arrangements.