MHRA approves Merck and Astellas/Pfizer’s bladder cancer treatment

Merck & Co’s Keytruda (pembrolizumab) and Astellas/Pfizer’s Padcev (enfortumab vedotin) have received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for use as an initial treatment option in advanced bladder cancer. This approval applies to the combination of these drugs for adults suffering from unresectable or metastatic urothelial carcinoma (UC) who are suitable candidates for platinum-containing chemotherapy.

This regulatory decision was influenced by positive findings from the KEYNOTE-A39/EV-302 late-stage clinical trial. In this study, patients treated with the Keytruda and Padcev combination exhibited a median overall survival of 31.5 months, in stark contrast to the 16.1 months observed in patients who received the standard platinum-containing chemotherapy. This represents a 53% reduction in the risk of death. Additionally, the combination therapy significantly improved progression-free survival, extending it to 12.5 months compared to 6.3 months with chemotherapy alone.

Globally, around 614,000 individuals are diagnosed annually with bladder cancer, with UC accounting for about 90% of these cases. Often, diagnosis occurs in advanced stages, where patients face particularly poor survival outcomes.

Thomas Powles, the primary investigator of the KEYNOTE-A39/EV-302 trial and director of Barts Cancer Institute Biomedical Research Centre, remarked on the significant progress in bladder cancer treatment. He noted that the foundational treatments for advanced bladder cancer had remained unchanged since the 1980s. He emphasized that the rapid transition of the KEYNOTE-A39/EV-302 trial results to a licensed treatment within a year underscores the trial's robust outcomes and the potential benefit for patients with advanced bladder cancer.

The combination of Keytruda and Padcev had already been approved for treating UC by both the US Food and Drug Administration and the European Commission prior to this MHRA approval.

Reflecting on the recent approval, Timir Patel, medical director at Astellas, UK, highlighted the extensive collaboration between the medical community and pharmaceutical companies that led to this achievement. Patel expressed optimism about the availability of this drug combination for doctors across the UK, emphasizing the positive impact it could have for patients.

Furthermore, this approval follows closely on the heels of another significant MHRA approval. Less than two months prior, Astellas’ monoclonal antibody Vyloy (zolbetuximab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, was approved as a first-line treatment for a specific subset of gastric cancer patients.

These developments reflect continuous advancements in cancer treatment options, driven by rigorous clinical research and collaboration between medical professionals and pharmaceutical companies, offering new hope for patients with severe and advanced forms of cancer.