Pembrolizumab (Keytruda)

Canada’s Drug Agency (CDA-AMC) recommends that Keytruda should be reimbursed by public drug plans for the treatment of adult patients, in combination with paclitaxel, with or without bevacizumab, with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumours express PD-L1 (combined positive score [CPS] ≥ 1) as determined by a validated test, and who have received 1 or 2 prior systemic treatment regimens if certain conditions are met. The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) determined that Keytruda plus paclitaxel, with or without bevacizumab, demonstrates acceptable clinical value versus placebo plus paclitaxel, with or without bevacizumab, in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumours express PD-L1 and who have received 1 or 2 prior systemic treatment regimens. This determination was enough for pERC to recommend that Keytruda be reimbursed. Given that Keytruda is expected to be an additive treatment to paclitaxel with or without bevacizumab, acceptable clinical value refers to incremental value compared to paclitaxel with or without bevacizumab. Evidence from a clinical trial showed that Keytruda plus paclitaxel, with or without bevacizumab, likely results in improvements in progression-free survival (PFS) and overall survival (OS) in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumours express PD-L1 and who have received 1 or 2 prior systemic treatment regimens when compared to placebo plus paclitaxel, with or without bevacizumab. Clinical trial data suggested that Keytruda may result in little to no difference in health-related quality of life (HRQoL) compared to placebo. The safety profile of Keytruda was considered to be consistent with the known safety profile of immunotherapy and expected to be manageable. Keytruda, when added on to paclitaxel with or without bevacizumab, addresses some of the needs identified by patients by delaying disease progression and prolonging survival.