Advancing bladder cancer treatment: EMA scrutinizes Astellas-Pfizer’s innovative therapy

A groundbreaking development in bladder cancer treatment is on the horizon as Astellas Pharma Inc. and Pfizer Inc. await the European Medicines Agency’s (EMA) review of their recent application. This significant step involves a Type II variation application for PADCEV (enfortumab vedotin) combined with KEYTRUDA (pembrolizumab), targeting first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).

The approval of this combination therapy could mark a revolutionary shift from the traditional platinum-containing chemotherapy, currently the standard care in first-line la/mUC treatment. This advancement is particularly significant given the annual diagnosis of approximately 200,000 bladder cancer cases in Europe.

Ahsan Arozullah, M.D., M.P.H., Senior Vice President, Head of Oncology Development at Astellas, highlighted the urgent need for improved treatment options in Europe for advanced stage urothelial cancer. He expressed hope in the combination therapy as a first-of-its-kind alternative to chemotherapy-based treatments.

EMA Reviews Astellas and Pfizer’s Groundbreaking Combo Therapy for Bladder Cancer

Echoing this sentiment, Roger Dansey, M.D., Chief Development Officer, Oncology at Pfizer, referenced the EV-302 pivotal trial’s findings. He emphasized the necessity for innovative treatments that extend the survival of patients, especially those facing advanced bladder cancer stages.

This application is anchored in the results of the Phase 3 EV-302 clinical trial. The study showcased that the combination therapy significantly improves overall survival (OS) and progression-free survival (PFS) compared to the existing platinum-containing chemotherapy. Furthermore, the safety profile of this combination was consistent with prior data, indicating no new safety concerns.

Decisions from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and the European Commission (EC) on this application are expected in 2024. It’s worth noting that the U.S. Food and Drug Administration has already given the green light to this therapy combination in December 2023.

The EV-302 trial, an essential component of a broader clinical program, evaluated the combination therapy across multiple stages of urothelial cancer and other solid tumors. The trial enrolled 886 patients and its results were prominently featured at the European Society for Medical Oncology (ESMO) Congress 2023.

The Astellas and Pfizer collaboration on this novel therapy is a beacon of hope in the oncology field. The potential EMA approval represents a critical turning point in the treatment of urothelial cancer, offering a promising alternative to conventional chemotherapy. This development underscores the importance of innovative research in advancing cancer treatment and improving patient outcomes.