Durvalumab (Imfinzi)

Canada’s Drug Agency (CDA-AMC) recommends that Imfinzi be reimbursed by public drug plans for the treatment of patients with muscle invasive bladder cancer (MIBC) in combination with gemcitabine-cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy if certain conditions are met. The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) determined that Imfinzi in combination with gemcitabine-cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy demonstrates acceptable clinical value versus neoadjuvant gemcitabine-cisplatin in patients with MIBC. Given that Imfinzi is expected to be an additive treatment to gemcitabine-cisplatin, acceptable clinical value refers to added value versus gemcitabine-cisplatin alone. Evidence from 1 clinical trial (NIAGARA) demonstrated that in patients with MIBC, treatment with Imfinzi in combination with gemcitabine-cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy resulted in a statistically significant improvement in pathologic complete response (pCR), event-free survival (EFS) at 24 months, and overall survival (OS) at 36 months compared to neoadjuvant gemcitabine-cisplatin and no adjuvant therapy after radical cystectomy. Imfinzi should only be covered for adults with stage T2N0-1M0 to T4aN0-1M0 bladder cancer who are eligible for surgery and have not received prior systemic chemotherapy or immunotherapy for the treatment of MIBC. Patients should also have a good performance status.