Retifanlimab (Zynyz)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Zynyz be reimbursed in combination with carboplatin and paclitaxel by public drug plans for the first-line treatment of adult patients with metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC).
• The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) determined that Zynyz in combination with carboplatin and paclitaxel demonstrates acceptable clinical value versus carboplatin and paclitaxel alone in patients with metastatic or inoperable locally recurrent SCAC in the first-line setting. This determination was sufficient for pERC to recommend that Zynyz be reimbursed. Given that Zynyz is expected to be an additive treatment to carboplatin and paclitaxel, acceptable clinical value refers to added value versus carboplatin and paclitaxel alone.
• Evidence from a clinical trial showed that Zynyz in combination with carboplatin and paclitaxel improved overall survival (OS) at 36 months and progression-free survival (PFS) at 24 months versus carboplatin and paclitaxel alone in patients with metastatic or inoperable locally recurrent SCAC in the first-line setting. In addition, Zynyz in combination with carboplatin and paclitaxel may have improved health-related quality of life (HRQoL) at the end of treatment compared with carboplatin and paclitaxel alone. Zynyz in combination with carboplatin and paclitaxel was associated with increased toxicity; however, the safety profile of Zynyz was considered to be consistent with the known safety profile of immunotherapy and expected to be manageable through standard clinical practices.
• Zynyz in combination with carboplatin and paclitaxel likely addresses some needs identified by patients, including extending OS and PFS and potentially improving HRQoL.