Merck and Astellas/Pfizer's bladder cancer combo gets positive CHMP opinion

The European Medicines Agency’s human medicines committee has endorsed the use of Merck & Co’s Keytruda (pembrolizumab) in combination with Astellas/Pfizer’s Padcev (enfortumab vedotin) as a first-line treatment for advanced bladder cancer. This recommendation specifically covers adults with unresectable or metastatic urothelial carcinoma (UC) who are eligible for platinum-containing chemotherapy.

Supported by data from the late-stage KEYNOTE-A39/EV-302 trial, this combination therapy demonstrated significant improvements in overall survival and progression-free survival compared to traditional platinum-based chemotherapy. This trial's positive results played a crucial role in the committee’s decision. Urothelial carcinoma represents the majority of bladder cancer cases, and over 165,000 people in the EU receive a bladder cancer diagnosis annually.

Currently, the primary treatment option for patients with advanced UC is platinum-containing chemotherapy. Ahsan Arozullah, senior vice president and head of oncology development at Astellas, highlighted the significance of the new combination therapy, suggesting it could transform the management of first-line treatment for this condition.

Keytruda has existing approval in the EU as a monotherapy for locally advanced or metastatic UC in adults who have previously undergone platinum-containing chemotherapy or are ineligible for cisplatin-containing chemotherapy. Similarly, Padcev is approved as a monotherapy for adults with advanced UC who have previously received both platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor.

If the Keytruda/Padcev combination receives approval, it will serve as the first and only alternative to platinum-containing chemotherapy for patients with advanced UC. Eliav Barr, senior vice president and head of global clinical development at Merck Research Laboratories, expressed anticipation for the European Commission’s decision, expected in the third quarter of 2024. Barr emphasized the potential of this combination to become a new first-line standard of care for treating advanced UC in the EU.

The combination therapy is also being evaluated for other stages of UC, including two phase 3 clinical trials focused on muscle-invasive bladder cancer. This ongoing research indicates a broader commitment to improving treatment options for various stages of UC, potentially expanding the benefits of the Keytruda and Padcev combination to a wider patient population.

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