Health Canada has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with enfortumab vedotin for adult patients with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy. The regimen is approved for use as neoadjuvant treatment before radical cystectomy and then continued afterward as adjuvant treatment.
Merck said the decision is based on results from the Phase 3 KEYNOTE-905 trial, also known as EV-303, which it conducted with Pfizer and Astellas. The trial showed a statistically significant improvement in event-free survival and overall survival for patients treated with KEYTRUDA plus enfortumab vedotin compared with radical cystectomy and pelvic lymph node dissection alone. It also showed a statistically significant difference in pathologic complete response rate.
The approval gives patients who cannot receive cisplatin-based chemotherapy another treatment option in a setting where needs remain high. Michelle Colero, executive director at Bladder Cancer Canada, said muscle-invasive bladder cancer can have a significant impact on patients and families, especially for those not candidates for cisplatin-based treatment. She added that the availability of an additional option is welcome news for the bladder cancer community and highlights the importance of continued research.
KEYTRUDA, known as pembrolizumab for injection, is one of Merck’s leading immunotherapy medicines. Enfortumab vedotin is an antibody-drug conjugate. Together, the two drugs are now approved in Canada for this perioperative bladder cancer setting in adults who are not eligible for cisplatin-containing chemotherapy.
The announcement adds Canada to the growing list of markets adopting the combination in muscle-invasive bladder cancer, reflecting increasing momentum for the regimen in perioperative care. Merck said the approval was supported by the trial data showing benefit across key efficacy measures.
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