Merck's KEYTRUDA Combo Therapy Approved in Canada for Bladder Cancer Patients
Health Canada has approved KEYTRUDA (pembrolizumab for injection), an anti-PD-1 therapy developed by Merck, in combination with enfortumab vedotin, for the treatment of adult patients with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy.
The approval is based on results from the pivotal Phase 3 KEYNOTE-905 trial, which demonstrated a statistically significant improvement in event-free survival and overall survival in patients treated with neoadjuvant and adjuvant KEYTRUDA in combination with enfortumab vedotin compared to radical cystectomy alone.
Bladder cancer is the fifth most commonly diagnosed cancer in Canada, with around one-quarter of newly diagnosed cases involving muscle-invasive bladder cancer. Cisplatin-based neoadjuvant chemotherapy followed by surgery is a standard treatment approach for patients with MIBC, but cisplatin ineligibility is common.
According to Michelle Colero, Executive Director at Bladder Cancer Canada, 'The availability of an additional treatment option for eligible patients is welcome news for the bladder cancer community and highlights the importance of continued research in this area of unmet need.'