Merck & Co’s – known as MSD outside the US and Canada – Keytruda (pembrolizumab) in combination with Astellas/Pfizer’s Padcev (enfortumab vedotin) has been recommended by the European Medicines Agency’s human medicines committee as a first-line treatment for advanced bladder cancer.
The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended the anti-programmed death receptor-1 therapy/antibody-drug conjugate combination 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 the combination demonstrated statistically significant and clinically meaningful improvements in overall survival and progression-free survival compared to platinum-based chemotherapy.
More than 165,000 people are diagnosed with bladder cancer in the EU every year and UC accounts for the vast majority of cases.
“Treatment options available to patients with unresectable or metastatic UC are currently limited mainly to platinum-containing chemotherapy,” explained Ahsan Arozullah, senior vice president and head of oncology development at Astellas.
“The data underpinning the CHMP’s approval recommendation shows that this combination could change how clinicians manage first-line treatment of this disease,” Arozullah said.
Keytruda is already approved in the EU as a monotherapy for locally advanced or metastatic UC in adults who have received prior platinum-containing chemotherapy and for adults who are not eligible for cisplatin-containing chemotherapy, while Padcev is indicated in the EU as a monotherapy for adults with locally advanced or metastatic UC who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor.
If approved, the Keytruda/Padcev combination will be the first and only alternative to platinum-containing chemotherapy for this patient population.
Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said the company “[looks] forward” to the European Commission’s decision on the combination, which is expected in the third quarter of 2024, and is “excited to be taking the first steps to provide a potential new first-line standard of care for the treatment of this disease in patients in the EU”.
The three companies are evaluating the combination in multiple stages of UC, including in two phase 3 clinical trials in muscle-invasive bladder cancer.