Pembrolizumab (Keytruda)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Keytruda, in combination with enfortumab vedotin, be reimbursed by public drug plans for the treatment of muscle invasive bladder cancer (MIBC) as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, if certain conditions are met.
• The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) determined that perioperative enfortumab vedotin plus Keytruda demonstrates acceptable clinical value versus surgery alone in patients with MIBC who are ineligible for cisplatin-containing chemotherapy. This determination was enough for pERC to recommend that Keytruda, in combination with enfortumab vedotin, be reimbursed. Given that enfortumab vedotin plus Keytruda is expected to be an additive treatment to surgery, acceptable clinical value refers to added value versus surgery alone.
• Evidence from 1 clinical trial (KEYNOTE-905) showed that perioperative enfortumab vedotin plus Keytruda and surgery improved overall survival (OS) and event-free survival (EFS) at 24 months, as well as a likely improvement in the pathological complete response rate versus radical cystectomy plus pelvic lymph node dissection (surgery alone) in patients with MIBC who are ineligible for cisplatin-containing chemotherapy.
• Keytruda, in combination with enfortumab vedotin, should only be covered when used as neoadjuvant treatment in adults with a confirmed diagnosis of MIBC who are eligible for surgery, ineligible for cisplatin-based chemotherapy, have not received previous treatment for MIBC, and have good performance status.
• Keytruda, in combination with enfortumab vedotin, should continue to be reimbursed only when used as adjuvant treatment after neoadjuvant treatment and bladder surgery have been completed and the total program cost of Keytruda is reduced. Adjuvant treatment should start within 6 months after surgery, and there should be no evidence of disease progression. Treatment should be stopped if there is disease progression, if adverse effects become unacceptable, or if the patient has received the maximum number of treatment cycles. Keytruda in combination with enfortumab vedotin should be prescribed by clinicians who have expertise and experience in treating bladder cancer.