Regulatory Decision Summary for Bavencio

Bavencio, an immunotherapy designed to enhance the immune systems ability to mount an anti-tumour response, was studied as monotherapy in a single-arm study designed to evaluate the safety and anti-tumour effect. Bavencio was associated with a modest overall response rate (ORR) (16.1%) in a difficult to treat patient population. The safety profile of Bavencio has been well characterized in the clinical trial setting and is considered to be consistent with other products that target the PD-1/PD-L1 signaling pathway. Bavencio is associated with a variety of immune-mediated adverse reactions, but these can be managed with close monitoring and prompt intervention following the guidance outlined in the Canadian product monograph. Given the lack of therapeutic options available to patients within the indication, the evidence provided in support of the efficacy of Bavencio is considered promising such that the preliminary assessment of benefit-risk can be considered favourable. Confirmation of efficacy in a well-controlled, randomized clinical study is necessary to confirm the benefit-risk balance for Bavencio and is a condition of authorization.