Merck & Co’s – known as MSD outside the US and Canada – Keytruda (pembrolizumab) and Astellas/Pfizer’s Padcev (enfortumab vedotin) have been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as a first-line combination treatment for advanced bladder cancer.
The PD-1 inhibitor/antibody-drug conjugate combination has been specifically authorised by the regulator to treat unresectable or metastatic urothelial carcinoma (UC) in adults who are eligible for platinum-containing chemotherapy.
The decision was supported by positive results from the late-stage KEYNOTE-A39/EV-302 trial, in which Keytruda plus Padcev resulted in a median overall survival of 31.5 months compared to 16.1 months with standard-of-care platinum-containing chemotherapy, representing a 53% reduction in risk of death.
The combination also significantly extended progression-free survival compared to chemotherapy, at 12.5 months versus 6.3 months.
Approximately 614,000 people are diagnosed with bladder cancer globally every year, with UC accounting for about 90% of all cases. Diagnosis often comes late, with many patients presenting with advanced or metastatic disease, at which point survival outcomes are particularly poor.
“The foundations of advanced bladder cancer treatment haven’t changed since the 1980s,” explained KEYNOTE-A39/EV-302 primary investigator Thomas Powles, director of Barts Cancer Institute Biomedical Research Centre. “To see [KEYNOTE-A39/EV-302] move from clinical trial to licensed indication within a year shows the strength of those results and the potential benefit to people with advanced bladder cancer.”
The Keytruda/Padcev combination has already been approved by the US Food and Drug Administration and European Commission for UC.
Commenting on the latest authorisation, Timir Patel, medical director, Astellas, UK, said: “Behind the news… is a tremendous amount of hard work and collaboration between the medical community and pharma.
“It’s testament to what we can achieve together and I look forward to doctors across the UK being able to access this combination of medicines for their patients.”
The approval comes less than two months after the MHRA approved Astellas’ monoclonal antibody Vyloy (zolbetuximab) in combination with fluoropyrimidine- and platinum-containing chemotherapy as a first-line treatment for a subset of gastric cancer patients.