- Merck announced that Health Canada approved Keytruda (pembrolizumab) plus enfortumab vedotin as neoadjuvant therapy followed by adjuvant treatment after radical cystectomy for adults with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.
- The approval is backed by the Phase 3 KEYNOTE-905 (EV-303) trial, conducted with Pfizer and Astellas, where the combination significantly improved event-free survival (EFS), overall survival (OS), and pathological complete response (pCR) versus surgery alone.
- In Canada, around 13,400 people are diagnosed with bladder cancer annually, with about 25% having MIBC. For patients unable to receive cisplatin due to age or comorbidities, treatment has traditionally relied on radical cystectomy alone, highlighting a major unmet need.
- The approval introduces a new perioperative treatment option for cisplatin-ineligible patients, expanding therapeutic choices and potentially improving outcomes for this high-risk bladder cancer population.
Takeaways:
The decision should expand use of Keytruda plus enfortumab vedotin in the perioperative setting by giving oncologists a data-backed option that improves event-free survival, overall survival, and pCR versus surgery alone, which could drive earlier adoption of immunotherapy plus ADC therapy in MIBC. Because the population is sizeable and previously underserved, this can strengthen Merck’s bladder cancer franchise, extend Keytruda’s lifecycle, and support broader use of combination immuno-ADC regimens, while also influencing provincial reimbursement and guideline updates.
Source: CA Newswire
