Bladder cancer therapy reduces risk of death by 50%

Bladder cancer

The US Food and Drug Administration (FDA) has approved antibody-drug conjugate (ADC) enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial cancer (la/mUC).

The approval is based on clinical data which found that Padcev plus pembrolizumab nearly doubled median overall survival compared to standard of care platinum-based chemotherapy.

In the Phase III EV-302 trial, median overall survival (OS) was 31.5 months for patients who received enfortumab vedotin-ejfv with pembrolizumab and 16.1 months for those who received platinum-based chemotherapy. Median progression-free survival (PFS) was 12.5 months compared to 6.3 months.

Thomas Powles, Professor of Genitourinary Oncology at Queen Mary University of London; Director, Barts Cancer Center, London; EV-302 Primary Investigator, said: “Advanced bladder cancer is a common cause of cancer-related death. The overall survival benefit seen in the EV-302 trial demonstrates the potential for Padcev in combination with pembrolizumab to impact first-line treatment of patients with locally advanced or metastatic urothelial carcinoma. In my opinion, this is a meaningful advancement over platinum-based chemotherapy in the systemic treatment of these patients.”

Enfortumab vedotin-ejfv was co-developed by Pfizer and Astellas. It is directed to Nectin-4, a protein highly expressed in bladder cancer. Nonclinical data suggest the treatment’s anticancer activity of is due to its binding to Nectin-4-expressing cells, followed by the internalisation and release of the anti-tumour agent monomethyl auristatin E into the cell.

Ahsan Arozullah, Senior Vice President, Head of Oncology Development, Astellas, commented: “Today’s FDA approval represents a paradigm change in the treatment of advanced bladder cancer. This achievement is notable, as it is the first regimen approved in advanced urothelial cancer that has demonstrated superiority to platinum chemotherapy, the gold standard of care for decades.”

Related Articles

Join FREE today and become a member
of Drug Discovery World

Membership includes:

  • Full access to the website including free and gated premium content in news, articles, business, regulatory, cancer research, intelligence and more.
  • Unlimited App access: current and archived digital issues of DDW magazine with search functionality, special in App only content and links to the latest industry news and information.
  • Weekly e-newsletter, a round-up of the most interesting and pertinent industry news and developments.
  • Whitepapers, eBooks and information from trusted third parties.
Join For Free